FDA Approves Komzifti (ziftomenib) for the Treatment of Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151)  announced the U.S. Food and Drug Administration (FDA)   approval of Komzifti™ (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Komzifti is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated (NPM1-m) AML, a devastating blood cancer with limited treatment options.

“Komzifti combines compelling efficacy, a favorable safety profile, compatibility with concomitant medications, and convenient once-daily oral administration in a population with few effective treatment options. These features highlight Komzifti’s potential to serve as the menin inhibitor of choice in its approved indication,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Together with our partner, Kyowa Kirin, we remain committed to advancing development of Komzifti across the treatment continuum for AML, where its best-in-class profile offers potential for even greater impact in combination regimens and earlier lines of therapy. We are fully prepared to launch Komzifti today and deliver this new medicine to patients in need.”

NPM1 mutations are among the most common founder mutations in AML, occurring in approximately 30% of cases. Historically, approximately 20% of patients with NPM1-m AML do not respond to front-line therapy. Of those who do respond, 70% will relapse within 3 years, most within 12 months. Early relapse and declining survival with each recurrence underscore the urgent need for treatment approaches that deliver lasting remission.

Approval is supported by the pivotal KOMET-001 trial (NCT04067336), which evaluated Komzifti’s safety and efficacy in 112 R/R NPM1-m AML patients. The rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 21.4% (95% CI: 14.2, 30.2). The median duration of CR+CRh was 5.0 months (95% CI: 1.9, 8.1) and the median time to first response in patients who achieved a CR or CRh was 2.7 months (range: 0.9 to 15 months). 88% of patients who achieved CR or CRh did so within 6 months of initiating Komzifti. These data from the Prescribing Information are generally consistent with findings recently published in the Journal of Clinical Oncology.1

“Komzifti addresses a critical need for adult patients with R/R NPM1-m AML, many of whom are older and unable to tolerate intensive chemotherapy or transplant,” said Eunice Wang, M.D., Chief of the Leukemia Service and Professor of Oncology at Roswell Park Comprehensive Cancer Center. “The clinical data demonstrate deep and durable responses with a manageable safety profile, including no drug-drug interactions and no Boxed Warnings for QTc prolongation or Torsades de Pointes – key advantages for patients on multiple concurrent medications. This approval equips physicians with a new oral therapy to integrate into care and improve outcomes for this vulnerable patient population.”

The most common adverse reactions (≥20%), including laboratory abnormalities, were aspartate aminotransferase increased, infection without an identified pathogen, potassium decreased, albumin decreased, alanine aminotransferase increased, sodium decreased, creatinine increased, alkaline phosphatase increased, hemorrhage, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, bilirubin increased, potassium increased, differentiation syndrome, pruritus, febrile neutropenia, and transaminases increased. Komzifti includes a Boxed Warning for differentiation syndrome, a well-studied mechanism-based risk in drugs that restore differentiation. Absence of clinically meaningful drug-drug interactions can ease the use of Komzifti with concomitant therapies, including those that cause QTc interval prolongation. QTc interval prolongation was ≤ Grade 3 in 12% of patients and no Grade 4 or Grade 5 QTc interval prolongation was reported. QTc interval prolongation of any cause occurred in 10% of the 70 patients 65 years of age or older.

“The approval of Komzifti underscores our commitment to advancing precision medicines to address the genetic drivers of disease in hematology and oncology,” said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. “In AML, where many patients face severe disease progression and limited treatment options, the evolution toward targeted therapies such as Komzifti represents a major step forward and offers potential to transform existing standards of care. We are proud to partner with Kura Oncology in bringing this important therapy to patients and their families.”

In November 2024, Kura Oncology and Kyowa Kirin entered into a global strategic collaboration to develop and commercialize Komzifti. The collaboration builds on Kyowa Kirin’s leadership and expertise in hematologic malignancies. Under the terms of the collaboration, Kura leads development, regulatory and commercial strategy in the U.S. and is responsible for manufacturing Komzifti. The companies will jointly perform certain commercialization activities in accordance with a co-created U.S. territory commercialization plan. Outside the U.S., Kyowa Kirin leads development, regulatory and commercial strategy and is responsible for commercializing Komzifti.

As part of its commitment to helping patients access Komzifti, Kura has established a support program, Kura RxKonnect™, to minimize barriers to access and reimbursement for appropriate patients prescribed Komzifti. Kura RxKonnect is available 8:00 am – 8:00 pm ET by phone at (844) KuraPSP (844-587-2777) or online at www.KuraRxKonnect.com.

https://en.wikipedia.org/wiki/Ziftomenib

FDA Approves Komzifti (ziftomenib) for the Treatment of Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

FDA Approves Cardamyst (etripamil) Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced  the U.S. Food and Drug Administration (FDA) approved its first commercial product, Cardamyst (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. Cardamyst is expected to be available in retail pharmacies in the first quarter of 2026.

Cardamyst nasal spray is a novel and rapid-acting calcium channel blocker delivered when needed to treat often highly symptomatic and unpredictable episodes of PSVT. With Cardamyst, adults with PSVT can be prepared wherever and whenever episodes occur, providing them with active management and a greater sense of control of their condition.

“Cardamyst is a novel at-the-ready treatment option that addresses the unpredictable impact of PSVT by offering patients the freedom to manage episodes anytime and anywhere,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “The FDA approval of Cardamyst is a watershed moment for Milestone and a gratifying event for our team members, patients, clinical investigators, and health care providers who participated in the development program, all of whom I sincerely thank for their dedication, counsel, and collaboration toward this important achievement.”

“Some people with PSVT have endured years of anxiety, fearing their next episode and the stress and disruption of emergency department visits,” said James Ip, M.D., FACC, FHRS, an etripamil investigator. “Cardamyst will give many of them the ability to administer a medication themselves that can quickly stop their PSVT episode and potentially avoid a hospital trip or a call to emergency services.”

Cardamyst Clinical Data

The FDA approval of Cardamyst is supported by a robust clinical trial program based on safety data from more than 1,800 participants and more than 2,000 episodes of PSVT. This includes the successful Phase 3 RAPID trial, a global, randomized, double-blind comparison of Cardamyst vs. placebo, published in The Lancet in 2023. In clinical studies, participants using Cardamyst were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with 64% of those who self-administered Cardamyst (N=99) converting from supraventricular tachycardia (SVT) to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR = 2.62; p<0.001). At one hour, the benefit was demonstrated in 73% of participants. In addition, significant reductions in time to conversion in those who took Cardamyst were evident early and durable, with a median time to conversion of 17 minutes (95% CI: 13.4, 26.5) for those treated with Cardamyst vs. 54 minutes (95% CI: 38.7, 87.3) for those treated with placebo.

A consistent safety profile and treatment effects were observed across all subgroups, including participants concurrently on beta blockers or calcium channel blockers. The most frequent adverse events occurring in ≥5% of participants in randomized clinical trials were mild-to-moderate and transient in nature, including local-site nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis. Less than 2% of trial participants discontinued therapy due to adverse events.

For more safety information about Cardamyst, please see Important Safety Information below. For the latest information about the product availability, please see https://milestonepharma.com/.

PSVT, also called SVT, is characterized by episodes of abnormally fast heart rate. Most people with PSVT experience multiple sustained episodes that require treatment on an annual basis. Until now, successful treatment options typically required IV administration in healthcare settings, creating stress and costs for patients and their insurers. Cardamyst offers a new approach to treat episodes of PSVT, enabling adults to self-administer the medication at the onset of symptoms. For more information, please visit SVTHearttoHeart.com.

“Our goal is that Cardamyst will become a trusted and essential solution for healthcare providers and their patients,” said Lorenz Muller, Chief Commercial Officer of Milestone. “Our team is focused on making Cardamyst available to adults with PSVT as quickly as possible, including actively working to secure insurance coverage and begin the distribution of the product through retail pharmacies.”

Annette Greene, Cardamyst clinical trial participant and administrator of the Supraventricular Tachycardia Group on Facebook, with more than 30,000 members, said, “Adults with SVT have been waiting a long time for the day when they can confidently self-administer Cardamyst to treat their SVT episodes. It is very exciting that the day has become a reality.”

Regarding future R&D, Milestone is poised to enter a Phase 3 program in atrial fibrillation with rapid ventricular rate (AFib-RVR), particularly on the strength of the successful ReVeRA Phase 2 trial in AFib-RVR, results of which were published in Circulation: Arrhythmia and Electrophysiology. Incorporating FDA’s guidance, Milestone has developed a Phase 3 registrational program to evaluate self-administered etripamil as a potential treatment for patients with AFib-RVR. When completed, the Company will be following a supplemental New Drug Application (sNDA) regulatory approval pathway for a potential second indication for etripamil in AFib-RVR. As such, Milestone will leverage the approved PSVT indication and the PSVT program data, along with a single pivotal Phase 3 study in patients with AFib-RVR.

https://en.wikipedia.org/wiki/Etripamil

FDA Approves Cardamyst (etripamil) Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia

FDA Approves Nuzolvence (zoliflodacin) for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA),   announced   the U.S. Food and Drug Administration (FDA)  approval of Nuzolvence (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. The development of Nuzolvence was part of a private, not-for-profit collaboration with The Global Antibiotic Research and Development Partnership (GARDP), which sponsored and led the Phase 3 clinical trial that supported FDA approval.

“The FDA’s approval of Nuzolvence marks a pivotal moment for patients and the broader healthcare community managing gonorrhea infections. For the first time in decades, both patients and their healthcare providers will have a single-dose, oral treatment option for uncomplicated urogenital gonorrhea,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics. “This achievement underscores our commitment to advancing innovative therapies for infectious diseases and fighting antimicrobial resistance. It highlights the strength of our development capabilities, as well as our collaboration with GARDP and the global scientific community.”

Gonorrhea is the second most common sexually transmitted bacterial infection worldwide, with more than 82 million new cases each year. In the United States alone, the Centers for Disease Control and Prevention (CDC) estimates that over 543,000 cases are reported each year and over 1 million incident cases occur annually,3 underscoring the significant public health impact. The highest rates are seen among sexually active men ages 20-24, though anyone who has unprotected sex can be at risk.4 Without timely treatment, gonorrhea can lead to serious and potentially permanent health complications.

"The decades-long absence of new gonorrhea treatments, combined with rising global antibiotic resistance, has created significant challenges in managing this common but potentially serious sexually transmitted infection," said Edward W. Hook III, M.D., Professor Emeritus of Medicine, University of Alabama at Birmingham, and lead investigator of the Phase 3 Nuzolvence trial. “In the pivotal Phase 3 study, Nuzolvence demonstrated non-inferiority compared to the current standard injectable therapy, including in infections caused by drug-resistant strains, while offering the convenience of a single oral dose.”

“A new antibiotic that does not require injection and can be used for patients who are allergic to penicillin or related drugs meets two important unmet needs in the treatment of gonorrhea,” added Dr. Hook.

The emergence and spread of global drug-resistant infections have led the World Health Organization (WHO) to identify antimicrobial resistance as one of the 10 most critical global health threats.5 The bacterium Neisseria gonorrhoeae has developed resistance to most classes of antibiotics used to treat these infections, including cephalosporins such as ceftriaxone, an injectable treatment, which is the currently recommended first line therapy for uncomplicated urogenital gonorrhea.

The Company plans to commercialize Nuzolvence in the second half of 2026, either in collaboration with a commercialization partner or independently.

https://en.wikipedia.org/wiki/Zoliflodacin

FDA Approves Nuzolvence (zoliflodacin) for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents

FDA Approves Myqorzo (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Cytokinetics, Incorporated (Nasdaq: CYTK) announced the U.S. Food and Drug Administration (FDA) approval of  Myqorzo™ (aficamten, 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Myqorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.

“This is a historic moment for our company and for the patients we serve, as we fulfill our promise to translate our science into medicines that may make a meaningful difference in patients’ lives,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Our first FDA approval stands as a testament to the strength of our science and the bold, trailblazing research that has defined Cytokinetics’ leadership in muscle biology. I’m pleased that the approved label and REMS reflect the distinct characteristics of Myqorzo including a straightforward, flexible dosing regimen, no requirement for drug-drug interaction monitoring and a predictable safety profile. I am profoundly grateful for the many years of passion and persistence shown by patients with obstructive HCM, as well as healthcare professionals, advocates, partners and employees who have contributed so importantly to reaching this key milestone.”

The full U.S. Prescribing Information for Myqorzo includes a Boxed WARNING for the risk of heart failure. Myqorzo reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments are required prior to and during treatment with Myqorzo to monitor for systolic dysfunction. Initiation of Myqorzo in patients LVEF <55% is not recommended. Decrease the dose of Myqorzo if LVEF <50% and ≥40%. Interrupt the dose of Myqorzo if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction. Because of the risk of heart failure due to systolic dysfunction, Myqorzo is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Myqorzo REMS Program. Please see additional Important Safety Information including Boxed WARNING below.

Myqorzo is expected to be available in the U.S. in the second half of January 2026. Cytokinetics will support patients with Myqorzo & You™, a personalized program for patients prescribed Myqorzo in the U.S. to help navigate the treatment journey, provide disease and product education, and offer support with insurance benefits investigations or financial assistance for those eligible. For more information, call 833-Myqorzo (833-697-6796).

“HCM is a heart muscle disease associated with a significant symptom burden. This approval of a new drug, Myqorzo, represents a meaningful addition to the treatment options available for symptomatic obstructive HCM patients,” said Martin Maron, M.D., Director, Hypertrophic Cardiomyopathy Center, Lahey Hospital and Medical Center, and Principal Investigator of SEQUOIA-HCM. “In SEQUOIA-HCM, Myqorzo improved exercise capacity and reduced symptoms while also being well-tolerated. For these reasons, Myqorzo represents an important step forward in how we care for people living with obstructive HCM.”

https://en.wikipedia.org/wiki/Aficamten

FDA Approves Myqorzo (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

FDA Approves Aqvesme (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases,  announced the U.S. Food and Drug Administration (FDA) approval of  Aqvesme (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. With this approved indication, Aqvesme becomes the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

“Thalassemia is a debilitating disease that demands lifelong management and vigilant monitoring for many life-threatening complications, such as blood clots, heart disease, and liver disease. Despite its severity, treatments have historically been limited, leaving some patients without any options,” said Hanny Al-Samkari, M.D., Peggy S. Blitz Endowed Chair in Hematology/Oncology at Mass General Brigham Cancer Institute, Associate Professor at Harvard Medical School, and an investigator for the mitapivat thalassemia Phase 3 clinical program. “The ENERGIZE and ENERGIZE-T Phase 3 trial results demonstrate that Aqvesme can help address anemia, fatigue, and the need for regular transfusions – key challenges of the disease. Today’s FDA approval represents an important step forward for individuals with thalassemia.”

The FDA approval of Aqvesme in thalassemia is based on results from the global, randomized, double-blind, placebo-controlled ENERGIZE and ENERGIZE-T Phase 3 trials in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, respectively. A total of 452 patients who are representative of the real-world thalassemia population were enrolled in the trials. The ENERGIZE and ENERGIZE-T Phase 3 trials met all primary and key secondary efficacy endpoints, demonstrating that Aqvesme improves hemolytic anemia and a key quality-of-life measure compared to placebo, including significant reductions in transfusion burden and significant improvements in hemoglobin and fatigue.

“Today is a landmark moment for the thalassemia community, bringing forward an innovative, disease-modifying oral medicine to address the urgent needs of people living with this devastating rare blood disorder,” said Brian Goff, Chief Executive Officer, Agios. “With this approval, Aqvesme becomes the only medicine indicated for the treatment of anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. We are deeply grateful to the patients, caregivers, healthcare providers, and advocacy partners who participated in and supported our clinical trials and helped ensure that our efforts reflected their priorities. Our focus now is on ensuring a successful launch and delivering meaningful impact for the community.”

“This year marks 100 years since thalassemia was first described in medical literature, and the progress we’ve made as a community is truly extraordinary,” said Ralph Colasanti, National President, Cooley’s Anemia Foundation. “Innovative medicines like Aqvesme help make this progress possible, offering new hope to patients like me by helping to address the complex needs and challenges of this disease. This approval provides an important new treatment option for the thousands of adults living with thalassemia in the U.S., including those with non-transfusion-dependent thalassemia who previously had no approved alternatives.”

In the ENERGIZE and ENERGIZE-T Phase 3 trials, five patients receiving Aqvesme experienced adverse reactions suggestive of hepatocellular injury (HCI), with two of these patients requiring hospitalization. These adverse reactions occurred within the first six months of exposure, and liver tests improved upon discontinuation of Aqvesme. To mitigate the risk of HCI, Aqvesme is available only through the Aqvesme REMS, a Risk Evaluation and Mitigation Strategy (REMS) program approved by the FDA. The Aqvesme REMS program requires liver tests prior to the first Aqvesme dose, every four weeks thereafter for 24 weeks, and then as clinically indicated. It also includes education and certification requirements for patients, prescribing physicians, and pharmacists, which are common components of REMS programs.

Due to the Aqvesme REMS program, mitapivat will be marketed under the brand name Aqvesme in the U.S. for the thalassemia indication. Mitapivat will continue to be marketed as Pyrukynd® (mitapivat) in the U.S. for the PK deficiency indication, which does not require a REMS program. Outside the U.S., mitapivat will continue to be marketed as Pyrukynd for its PK deficiency and thalassemia indications in regions where it is approved, and will retain this name upon approval in regions currently under regulatory review.

Agios expects Aqvesme to be available in the U.S. in late January 2026, following implementation of the Aqvesme REMS program. For more information, visit Aqvesme.com.

About Thalassemia

Thalassemia is a rare, inherited blood disease that affects the production of hemoglobin, the protein in red blood cells responsible for carrying oxygen throughout the body. The disease is categorized into two main types: alpha-thalassemia and beta-thalassemia, depending on which globin chain of the hemoglobin is affected. By disrupting hemoglobin production, thalassemia reduces the number of circulating red blood cells and shortens their lifespan, which leads to anemia, fatigue, and serious complications.

Some individuals with thalassemia require regular transfusions (classified as transfusion-dependent thalassemia), while others only need them intermittently (classified as non-transfusion-dependent thalassemia). All patients with thalassemia experience a significant disease burden, including comorbidities, reduced quality of life, and shortened life expectancy.

In the U.S., approximately 6,000 adult patients are diagnosed with thalassemia.

About ENERGIZE and ENERGIZE-T

ENERGIZE (NCT04770753) and ENERGIZE-T (NCT04770779) are global, double-blind, placebo-controlled Phase 3 trials evaluating the efficacy and safety of mitapivat in adults with alpha- or beta-thalassemia.

The ENERGIZE trial randomized 194 non-transfusion-dependent alpha- or beta-thalassemia patients 2:1 to receive either mitapivat 100 mg twice daily or placebo. The primary endpoint was hemoglobin response, defined as an increase of ≥1.0 g/dL in average hemoglobin concentration from Week 12 through Week 24 compared with baseline. Key secondary endpoints included changes from baseline in average fatigue scores and in average hemoglobin concentration from Week 12 to Week 24. The trial also assessed safety and tolerability.

The ENERGIZE-T trial randomized 258 transfusion-dependent alpha- or beta-thalassemia patients 2:1 to receive either mitapivat 100 mg twice daily or placebo. The primary endpoint was transfusion reduction response, defined as a ≥50% reduction in transfused red blood cell (RBC) units with a reduction of ≥2 units of RBCs transfused in any consecutive 12-week period through Week 48 compared with baseline. Several transfusion reduction measures were included as key secondary endpoints, and achievement of transfusion independence was a secondary endpoint. The trial also assessed safety and tolerability.

For each trial, patients who completed the double-blind phase had the option to transition into a corresponding open-label extension phase, during which all patients receive mitapivat.

https://en.wikipedia.org/wiki/Mitapivat

FDA Approves Aqvesme (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

FDA Approves Clotic (clotrimazole otic solution), First Treatment with Clinical Evidence for Fungal Ear Infections

In continuation of my update on clotrimazole

Laboratorios Salvat, S.A. ("Salvat") announced today that the U.S. Food and Drug Administration (FDA) has approved Clotic (clotrimazole otic solution), the first and only treatment with clinical evidence specifically indicated for fungal otitis externa (otomycosis).

About Clotic

Clotic is a broad-spectrum otic antimycotic agent containing clotrimazole, an azole antifungal that inhibits fungal enzyme production essential for survival. The medication works by blocking cytochrome P450-dependent enzymes, damaging fungal cell walls and disrupting growth, ultimately causing cell death. This preservative-free formulation is administered as ear drops using innovative Blow-Fill-Seal technology in single-dose vials.

Clotic is indicated for the treatment of fungal otitis externa (otomycosis) in adults 18 years of age and older, specifically targeting infections caused by Aspergillus species and Candida species. The treatment is approved only for patients with intact tympanic membranes.

The FDA approval of Clotic was based on comprehensive clinical data demonstrating well-recognized safety and efficacy in treating pathogenic dermatophytes, yeasts, and several species of fungus affecting the outer ear canal. The approval package included analytical and clinical evidence supporting Clotic's effectiveness as the first clinically proven treatment option for otomycosis.

Clotic is administered twice daily for 14 days, with each single-dose vial (1%/0.17mL) delivering the complete treatment dose. The innovative packaging protects the preservative-free formulation from humidity and contamination while ensuring precise dosing.

The approval of Clotic marks an important milestone in addressing an underserved therapeutic area, offering the first FDA-approved treatment specifically designed and clinically validated for fungal otitis externa in adult patients.

https://pubchem.ncbi.nlm.nih.gov/compound/Clotrimazole#section=2D-Structure

FDA Approves Clotic (clotrimazole otic solution), First Treatment with Clinical Evidence for Fungal Ear Infections

FDA Approves Linzess (linaclotide) for Children 7 Years and Older with Irritable Bowel Syndrome with Constipation

The U.S. Food and Drug Administration (FDA) has approved Linzess (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess is the first treatment approved for IBS-C in pediatric patients.

Disease or Conditions

IBS-C is a common condition affecting children and adolescents characterized by chronic constipation (which occurs when patients have infrequent bowel movements with hard stools that may be difficult or painful to pass), abdominal pain, and bloating. There is no known underlying organic cause and there are typically multiple contributing factors.

Efficacy

The effectiveness of Linzess to treat IBS-C was established in pediatric patients 7 years and older. Linzess for this indication was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7 to 17 years who met modified Rome III criteria for child/adolescent IBS-C. The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two spontaneous (i.e., naturally occurring) bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period. The efficacy results were consistent with results demonstrated in the adult IBS-C population.

Safety

The safety of Linzess in these clinical studies was similar in adult and pediatric patients. The most common side effect reported in pediatric patients 7 to 17 years with IBS-C was diarrhea. If severe diarrhea occurs, patients should discontinue Linzess and be rehydrated. Patients younger than 2 years can be at risk of serious dehydration and should not take Linzess for any indication, nor should patients with known or suspected mechanical gastrointestinal obstruction (bowel blockage). See the full prescribing information for additional information on risks associated with Linzess.

The recommended dosage for pediatric patients 7 years and older with IBS-C is 145 mcg orally once daily.

https://en.wikipedia.org/wiki/Linaclotide

FDA Approves Linzess (linaclotide) for Children 7 Years and Older with Irritable Bowel Syndrome with Constipation

FDA Approves Caplyta (lumateperone) as an Adjunctive Therapy for the Treatment of Major Depressive Disorder (MDD) in Adults

In continuation of my update on lumateperone

Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) approval of  Caplyta® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval – the first under J&J leadership following its acquisition of Intra-Cellular Therapies, Inc. – provides patients with a safe and effective new treatment option that can enable a path to remission. Caplyta® makes it easy to start and stay on treatment without the need for titration. Weight gain and other metabolic side effects that typically lead to discontinuation of care were similar to placebo. This approval marks the fourth indication for Caplyta®, the first and only FDA-approved treatment for bipolar I and II depression in adults, as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults.

MDD, or clinical depression, is one of the most common psychiatric disorders, affecting about 22 million American adults.4,5 While oral antidepressants may offer relief for some, 2 in 3 people living with MDD continue to experience residual symptoms despite treatment, significantly impacting their overall quality of life.6 Beyond its toll on patients’ wellbeing, MDD has a substantial economic burden and is the leading cause of disability in the U.S.7

“Depression is a complex disorder that affects each person differently, underscoring the urgent need for a range of effective and well-tolerated treatment options,” said Roger S. McIntyre, M.D., FRCPC, Professor of Psychiatry and Pharmacology, University of Toronto.a “For people who are still experiencing lingering depressive symptoms while on an antidepressant, adding Caplyta® to a patient’s treatment regimen may offer early improvement, with the potential for remission—the ultimate goal of treatment.”

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials – Study 501 and 502 – which both met their primary and key secondary endpoints, providing statistically significant and clinically meaningful improvement in depression symptoms compared to an oral antidepressant plus placebo, as measured by Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression Scale-Severity index (CGI-S) total scores.1,2

A large separation in total MADRS score was seen between Caplyta® and placebo in Study 501 (-4.9 points, effect size 0.61) and Study 502 (-4.5 points, effect size 0.56), at six weeks. Separation from placebo was seen as early as one week in Study 501 and two weeks in Study 502. Significant reductions in the key secondary endpoint of mean change in total CGI-S scores from baseline were also demonstrated at six weeks in Study 501 (-0.7 points, effect size 0.67) and Study 502 (-0.5 points, effect size 0.51).1,2

In pivotal trials, the Caplyta® safety profile was consistent with the existing body of clinical data in its schizophrenia and bipolar depression I and II indications. No new safety concerns were identified. Weight gain and metabolic changes (lipid and glucose levels), as well as akathisia and restlessness, were similar to placebo. Reports of sexual side effects were not common. The most common side effects of Caplyta® include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea.

“Major depressive disorder affects millions of Americans, impacting how a person feels, thinks, and acts,” said Michael Pollock, CEO of Depression and Bipolar Support Alliance (DBSA). “DBSA believes that all individuals have the right to direct their own treatment, and we understand that for many people, ongoing antidepressant therapy alone may not offer meaningful relief. The introduction of new treatment options, and continued innovation in mental health, has enabled us to reset expectations for living with depression and offers people hope that achieving lasting wellness and remission is possible.”

Long-term data, evidenced by the 503 open-label extension safety study, showed Caplyta® was safe and well tolerated, consistent with the safety profile of Studies 501 and 502. Patients experienced low risk of weight gain, cardiometabolic effects, and extrapyramidal symptoms.8 Caplyta® also demonstrated the potential to help patients achieve remission. During this 26-week safety study, 80% of patients responded to treatment and 65% of patients experienced remission (defined as MADRS Total score ≤ 10) at 6 months.3

Although its exact mechanism of action is unknown, Caplyta® is characterized by high serotonin 5-HT2A receptor occupancy and moderate amounts of dopamine D2 receptor occupancy at therapeutic doses. Caplyta® does not need dose titration, allowing patients to start treatment at the effective dose of 42 mg.8

“Caplyta® has the potential to become a new standard of care across multiple mental health disorders, including major depressive disorder,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “This approval is a testament to our nearly 70-year commitment of bringing innovative and differentiated therapies that redefine treatment expectations—and introduce the possibility of remission—to patients living with some of today’s most prevalent and debilitating mental health conditions.”

This additional FDA approval builds upon the established, robust clinical efficacy and proven real-world safety profile of Caplyta® for the treatment of adults living with schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder.

A supplemental New Drug Application (sNDA) for Caplyta® with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia was recently submitted to the FDA. The medication is also being studied for other neuropsychiatric and neurological disorders. Caplyta® is not FDA-approved for these disorders.

https://en.wikipedia.org/wiki/Lumateperone

FDA Approves Caplyta (lumateperone) as an Adjunctive Therapy for the Treatment of Major Depressive Disorder (MDD) in Adults

FDA Approves Zoryve for Atopic Dermatitis in Young Children

In continuation of my update on Zoryve

The U.S. Food and Drug Administration has approved the supplemental new drug application for Zoryve (roflumilast) cream 0.05 percent for the topical treatment of mild-to-moderate atopic dermatitis in children 2 to 5 years of age.

The once-daily cream can be used anywhere on the body and for any duration. This approval offers an alternative to steroids.

The approval is based on clinical trials that showed Zoryve cream rapidly improved the severity and extent of eczema signs and symptoms, with approximately 40 percent of children achieving a 75 percent improvement from baseline on the Eczema Area and Severity Index. Additionally, more than one-third of participants (35 percent) achieved clinically meaningful improvement in itch intensity in four weeks.

"Young children are particularly vulnerable to the bothersome symptoms of atopic dermatitis, because their immune system and skin barrier are less developed than those of older children and adults," Korey Capozza, founder and executive director at Global Parents of Eczema Research, said in a statement. "This condition doesn't just affect the child's skin -- it can affect the whole family by causing sleep disruption, emotional distress, and social isolation."

Approval of Zoryve was granted to Arcutis Biotherapeutics.

More Information

FDA Approves Zoryve for Atopic Dermatitis in Young Children 

FDA Approves Kygevvi (doxecitine and doxribtimine) for the Treatment of Thymidine Kinase 2 Deficiency

UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that Kygevvi has been granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency (TK2d), with an age of symptom onset on or before 12 years.1 It is the first and only approved treatment for these patients living with TK2d.

TK2d is an ultra

Doxecitine/doxribtimine

-rare, life-threatening, genetic mitochondrial disease characterized by progressive (worsening over time) and severe muscle weakness (myopathy) with no approved treatment options beyond supportive care until now.2,3,4,5 It is often fatal, with those experiencing initial symptoms on or before the age of 12 years facing a high risk of premature death (often occurring within 3 years after symptom onset).6 It is estimated that the worldwide prevalence of TK2d is 1.64 [0.5, 3.1] cases per 1,000,000 people.7

“The approval of doxecitine and doxribtimine represents a pivotal moment for the TK2d community who previously had no FDA-approved treatment options for this rare genetic mitochondrial disease beyond supportive [palliative] care,” said Donatello Crocetta, Chief Medical Officer at UCB. “We extend heartfelt thanks to the patients, families and friends, advocates, healthcare providers and dedicated clinical trial teams who have partnered with us on this important journey.”

“It’s hard to overstate the importance of this FDA approval for those diagnosed with TK2d. This is an ultra-rare disease community in dire need of treatment options. For too long, caregivers and their families have had to endure the burden of this disease," said Kristen Clifford, United Mitochondrial Disease Foundation President and CEO. “Having the first-ever FDA-approved therapy for TK2d in this patient population not only meets a critical medical need - it represents something greater - hope for the future."

“I’ve been studying mitochondrial diseases for more than three decades and have witnessed firsthand the impact TK2d has on patients and their families. We have been waiting for an approved treatment for many years, and this approval marks a significant milestone in how we can support and manage this debilitating condition,” said Dr. Michio Hirano, Professor of Neurology and Chief of the Division of Neuromuscular Medicine at Columbia University Irving Medical Center.

Supporting data

The Kygevvi approval is supported by safety and efficacy data from one Phase 2 clinical study, two retrospective chart review studies, and an expanded access use program*.1,8,9,10,11 These studies included a total of 82 unique patients treated with Kygevvi or pyrimidine nucleosides with an age of TK2d symptom onset ≤12 years. Efficacy was assessed by comparing overall survival in these pediatric and adult treated patients to an external control group of untreated patients who were matched to treated patients using age of TK2d symptom onset (≤ 2 years or >2 to ≤ 12 years).1 A total of 78 matched pairs were identified. The results showed that survival time from treatment start was improved; treatment reduced the overall risk of death from treatment start by approximately 86% (95% CI: 61%, 96%).1 Of the 78 treated patients included in the survival analysis, the median age of TK2d symptom onset was 1.5 years (range: 0.01 to 12 years).1 The median duration of treatment was 4 years (range: 1 day to 12 years) and the median dose received was 762 mg/kg/day (range: 260 to 800 mg/kg/day).1

The most common adverse reactions (incidence ≥5%) are diarrhea, abdominal pain (including abdominal pain upper), vomiting, alanine aminotransferase increased (ALT), and aspartate aminotransferase increased (AST).1

A regulatory review of doxecitine and doxribtimine is currently underway by the EMA (European Medicines Agency), and further regulatory submissions are planned. Kygevvi is currently not approved for use in any indication by any regulatory authority outside of the U.S. UCB expects Kygevvi to be commercially available in the U.S. in Q1, 2026. To further its mission of equitable care, UCB will provide a personalized support program for Kygevvi that places the needs of patients and caregivers at the forefront.

In the U.S., Kygevvi received Orphan Drug, Breakthrough, Priority Review and Rare Pediatric Disease designations from the FDA.12,13 With this approval by FDA, UCB was awarded a Rare Pediatric Disease Priority Review Voucher (RPDPRV) redeemable for a priority review for a future marketing application.

About Kygevvi

Kygevvi is a combination of doxecitine and doxribtimine, both pyrimidine nucleosides, indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.1 Administration of Kygevvi is intended to incorporate the pyrimidine nucleosides, deoxycytidine and deoxythymidine, into skeletal muscle mitochondrial DNA.1 This action restores mitochondrial DNA copy number in TK2d mutant mice.1

Important safety information for Kygevvi1

Increase in Liver Transaminases

Elevated liver transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels were reported in patients treated with Kygevvi. Obtain baseline liver transaminase (ALT, AST) and total bilirubin levels in patients prior to treatment initiation with Kygevvi. If signs or symptoms consistent with liver injury are observed, interrupt treatment with Kygevvi until liver transaminase (ALT, AST) and total bilirubin levels have either returned to baseline or stabilized at a new baseline value. Consider permanently discontinuing Kygevvi if signs or symptoms consistent with liver injury persist or worsen. Monitor liver transaminases and total bilirubin levels yearly and as clinically indicated.

Gastrointestinal Adverse Reactions

Diarrhea and vomiting leading to hospitalization, dose reduction, and permanent discontinuation were reported in patients treated with Kygevvi. Based on the severity of the diarrhea and/or vomiting, reduce the dosage of Kygevvi or interrupt treatment until diarrhea and/or vomiting improves or returns to baseline. Consider restarting Kygevvi at the last tolerated dose, and increase the dose as tolerated. For persistent or recurring diarrhea and/or vomiting, consider discontinuing Kygevvi permanently and provide supportive care with electrolyte repletion as clinically indicated.

https://en.wikipedia.org/wiki/Doxecitine/doxribtimine

FDA Approves Kygevvi (doxecitine and doxribtimine) for the Treatment of Thymidine Kinase 2 Deficiency

FDA Approves Epioxa (riboflavin 5’-phosphate) Ophthalmic Solution for the Treatment of Keratoconus

Glaukos Corporation, an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced  the U.S. Food and Drug Administration (FDA) approval of its Epioxa™ HD / Epioxa™ (“Epioxa”) New Drug Application (NDA). Epioxa is a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated.

Epioxa represents a transformative innovation in keratoconus care, offering an incision-free alternative to traditional corneal cross-linking procedures as it does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. This novel, oxygen-enriched topical therapeutic, bioactivated by UV light, is designed to eliminate the pain associated with removal of the epithelium, streamline the procedure, and minimize recovery, all while delivering clinically meaningful outcomes and exceptional value to patients, providers, and the healthcare system. Epioxa is based on two formulations, Epioxa HD and Epioxa, that are sequentially administered during the cross-linking procedure followed by UV activation in an oxygen-enriched environment.

“The FDA approval of Epioxa ushers in a new standard-of-care for patients suffering from keratoconus with the first FDA-approved topical drug therapy that does not require removal of the corneal epithelium,” said Thomas Burns, Glaukos chairman and chief executive officer. “Epioxa is designed to significantly improve patient comfort and minimize recovery time, representing a game-changing new treatment for patients suffering from keratoconus. We appreciate the clinical investigators and study participants in the clinical trials for their instrumental roles in helping us reach this important advancement. This approval marks a major milestone in our mission to improve patient access to sight-saving therapies, and we are excited to bring this transformative therapy to market for the benefit of patients.”

“Keratoconus is currently an underdiagnosed and undertreated disease. For keratoconus patients who are fortunate enough to be diagnosed, the current standard-of-care requires removal of the epithelium, the top layer of the cornea. The pain and extended healing time associated with the current surgical procedure are major barriers to adoption,” said W. Barry Lee, MD, corneal specialist at Eye Consultants of Atlanta and President of the Cornea Society. “As an incision-free treatment that does not require removal of the epithelium, I expect the newly approved Epioxa treatment to address both of these major concerns.”

The FDA approval of Epioxa is based on results from two prospective, randomized, multicenter, double-masked, Phase 3 pivotal trials that randomized a total of over 400 patients. Both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.

Glaukos intends for Epioxa to be commercially available in the first quarter of 2026. With this approval, Glaukos plans to make substantial investments in patient awareness and access while addressing the longstanding challenges of underdiagnosis and undertreatment that have affected this rare disease patient community. These efforts will be focused on supporting patients and families across every step of the journey, from awareness to diagnosis and treatment. Key initiatives include streamlined patient access support programs, a co-pay assistance program to reduce financial barriers, integrated healthcare professional (HCP) and patient-centric strategies to improve education and engagement, and broad awareness and detection programs aimed at earlier and more widespread screening for and diagnosis of the disease.

Keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea that is often most aggressively advancing in patients under the age of 30. If left untreated, keratoconus can lead to loss of visual function and even blindness and is one of the leading causes of corneal transplants (penetrating keratoplasty) in the United States. Approximately 90% of cases of keratoconus are bilateral and as many as 20% of untreated keratoconus patients ultimately require a corneal transplant. Conventional keratoconus treatments such as eyeglasses or contact lenses address visual symptoms only and do not slow or halt underlying disease progression.

Glaukos’ first-generation corneal cross-linking therapy, known as Photrexa® Viscous / Photrexa®, which requires removal of the corneal epithelium, received U.S. FDA approval in 2016 as an orphan drug and has since been the first-and-only FDA-approved corneal cross-linking therapy for the treatment of keratoconus. There are more than 300 peer-reviewed publications supporting the performance and safety of Glaukos’ cross-linking therapies.

For more information about Epioxa HD / Epioxa and Full Prescribing Information, please visit www.Epioxa.com.

FDA Approves Epioxa (riboflavin 5’-phosphate) Ophthalmic Solution for the Treatment of Keratoconus

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections

In Continuation of my update on fosfomycin

The U.S. Food and Drug Administration (FDA) has approved Contepo (fosfomycin) for injection for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae.

Contepo is an epoxide antibacterial that works by disrupting bacterial cell wall synthesis through covalently binding and inhibiting phosphoenolpyruvate transferase (MurA), thereby blocking the synthesis of peptidoglycan. The drug is bactericidal against Enterobacterales.

Dosing and Administration

The recommended dosage of Contepo is 6 grams administered every 8 hours by intravenous infusion over 1 hour in patients 18 years of age or older with an estimated creatinine clearance greater than 50 mL/min. The duration of therapy is up to 14 days and should be guided by the severity of infection and the patient's clinical status. Dosage adjustments are required for patients with renal impairment.

Clinical Trial Results

The FDA approval was based on data from a multinational, double-blind clinical trial (Trial 1) that enrolled 464 adults hospitalized with cUTI, including acute pyelonephritis. The study compared Contepo 6 grams intravenously every 8 hours to piperacillin/tazobactam 4.5 grams intravenously every 8 hours for 7 days of therapy, with treatment allowed for up to 14 days in bacteremic patients.

In the microbiological modified intent-to-treat (mMITT) population of 339 patients, Contepo demonstrated efficacy with regard to overall response at the test-of-cure visit. Overall success, defined as clinical cure plus microbiological eradication, was achieved in 63.5% (108/170) of Contepo-treated patients compared to 55.6% (94/169) of piperacillin/tazobactam-treated patients.

Important Safety Information

The most common adverse reactions (incidence ≥2%) observed in clinical trials were transaminase elevations, hypokalemia, neutropenia, nausea, vomiting, diarrhea, hypocalcemia, hypernatremia, headache, and hypophosphatemia.

Contepo contains 1,980 mg of sodium in each vial. The high sodium load associated with its use may result in changes in serum electrolytes, such as increased levels of serum sodium and decreased levels of potassium, calcium, and phosphorus. A low-sodium diet is recommended during Contepo treatment, and healthcare providers should monitor serum electrolyte levels and fluid status during treatment.

Contepo has been shown to prolong the QT interval in some patients and should be avoided in patients with known QT prolongation or ventricular arrhythmias, including a history of torsade de pointes. Healthcare providers should monitor electrolytes during treatment with Contepo.

Contepo is contraindicated in patients with known serious hypersensitivity to fosfomycin or any of the excipients.

Postmarketing Requirements

As part of the approval, the FDA has required Meitheal Pharmaceuticals to conduct postmarketing studies, including:

Pediatric pharmacokinetic and safety studies in children from birth to less than 18 years of age

A clinical lactation study to determine fosfomycin concentrations in human milk

A five-year U.S. surveillance study to monitor resistance or decreased susceptibility to fosfomycin in target bacterial populations.

About Complicated Urinary Tract Infections

Complicated urinary tract infections are infections of the urinary tract that occur in patients with structural or functional abnormalities of the urinary tract or with underlying diseases that increase the risk of acquiring infection or failing therapy. Acute pyelonephritis is a severe form of urinary tract infection involving the kidney.

https://en.wikipedia.org/wiki/Fosfomycin

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections

The U.S. Food and Drug Administration (FDA) has approved Contepo (fosfomycin) for injection for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae.

Contepo is an epoxide antibacterial that works by disrupting bacterial cell wall synthesis through covalently binding and inhibiting phosphoenolpyruvate transferase (MurA), thereby blocking the synthesis of peptidoglycan. The drug is bactericidal against Enterobacterales.

Dosing and Administration

The recommended dosage of Contepo is 6 grams administered every 8 hours by intravenous infusion over 1 hour in patients 18 years of age or older with an estimated creatinine clearance greater than 50 mL/min. The duration of therapy is up to 14 days and should be guided by the severity of infection and the patient's clinical status. Dosage adjustments are required for patients with renal impairment.

Clinical Trial Results

The FDA approval was based on data from a multinational, double-blind clinical trial (Trial 1) that enrolled 464 adults hospitalized with cUTI, including acute pyelonephritis. The study compared Contepo 6 grams intravenously every 8 hours to piperacillin/tazobactam 4.5 grams intravenously every 8 hours for 7 days of therapy, with treatment allowed for up to 14 days in bacteremic patients.

In the microbiological modified intent-to-treat (mMITT) population of 339 patients, Contepo demonstrated efficacy with regard to overall response at the test-of-cure visit. Overall success, defined as clinical cure plus microbiological eradication, was achieved in 63.5% (108/170) of Contepo-treated patients compared to 55.6% (94/169) of piperacillin/tazobactam-treated patients.

Important Safety Information

The most common adverse reactions (incidence ≥2%) observed in clinical trials were transaminase elevations, hypokalemia, neutropenia, nausea, vomiting, diarrhea, hypocalcemia, hypernatremia, headache, and hypophosphatemia.

Contepo contains 1,980 mg of sodium in each vial. The high sodium load associated with its use may result in changes in serum electrolytes, such as increased levels of serum sodium and decreased levels of potassium, calcium, and phosphorus. A low-sodium diet is recommended during Contepo treatment, and healthcare providers should monitor serum electrolyte levels and fluid status during treatment.

Contepo has been shown to prolong the QT interval in some patients and should be avoided in patients with known QT prolongation or ventricular arrhythmias, including a history of torsade de pointes. Healthcare providers should monitor electrolytes during treatment with Contepo.

Contepo is contraindicated in patients with known serious hypersensitivity to fosfomycin or any of the excipients.

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections