Thursday, May 11, 2017

New drug could help decrease symptoms of asthma

"This new drug could be a game changer for future treatment of asthma" - Professor Chris Brightling, NIHR Senior Research Fellow at the University of Leicester.

Fevipiprant.svg

The first new asthma pill for nearly 20 years has the power to significantly reduce the severity of the condition, a study led by the University of Leicester has found.

The research was funded by Novartis Pharmaceuticals, National Institute for Health Research (NIHR) and the EU (AirPROM), and is described by the lead researcher as "a game changer for future treatment of asthma."

Three people die every day because of asthma attacks and research shows that two thirds of asthma deaths are preventable, according to Asthma UK.

Fevipiprant (QAW039) significantly decreased the symptoms of asthma, improved lung function, reduced inflammation and repaired the lining of airways.

The drug is currently being evaluated in late stage clinical trials for efficacy in patients with severe asthma, according to ClinTrials.gov.

A total of 61 people took part in the research. One group was given 225mg of the drug twice a day for 12 weeks and the other participants were assigned to a placebo group. Fevipiprant and the placebo were added to the medications the participants were already taking.

The study was designed primarily to examine the effects on inflammation in the airway by measuring the sputum eosinophil count.

The sputum eosinophil is an inflammation measurement of a white blood cell that increases in asthma and is used to assess the severity of this condition.

People who do not have asthma have a percentage of less than one and those with moderate-to-severe asthma typically have a reading of about five per cent.

The rate in people with moderate-to-severe asthma taking the medication was reduced from an average of 5.4 percent to 1.1 percent over 12 weeks, according to the study published today in the prestigious The Lancet Respiratory Medicine journal.

Professor Christopher Brightling, who is a NIHR Senior Research Fellow and Clinical Professor in Respiratory Medicine at the University of Leicester, led the study at the NIHR Respiratory Biomedical Research Unit, which is based at the Glenfield Hospital in Leicester.

Professor Brightling said: "A unique feature of this study was how it included measurements of symptoms, lung function using breathing tests, sampling of the airway wall and CT scans of the chest to give a complete picture of how the new drug works.

"Most treatments might improve some of these features of disease, but with Fevipiprant improvements were seen with all of the types of tests.

"We already know that using treatments to target eosinophilic airway inflammation can substantially reduce asthma attacks.

"This new treatment, Fevipiprant, could likewise help to stop preventable asthma attacks, reduce hospital admissions and improve day-to-day symptoms- making it a 'game changer' for future treatment."

Gaye Stokes from Grantham in Lincolnshire has had severe asthma for 16 years. She took part in the trial and was part of the Fevipiprant group.

The 54-year-old said: "I knew straight away that I had been given the drug. I felt like a completely different person. I had more get up and go, I was less wheezy and for the first time in years I felt really, really well.

"For me, it felt like a complete wonder drug and I can't wait for it to be available because I really think it could make a huge difference to me."
After the 12 week trial and Gaye stopped receiving the drug, she said her health started to "go downhill again very quickly".

Professor Brightling added that the latest advance underpinned the work of the Leicester Precision Medicine Institute, a Centre of Excellence that coalesces and aligns the research missions of the University of Leicester and the NHS in Leicester.

Future treatment of human disease will increasingly move from a 'one size fits all' approach to one of tailoring the treatment to the individual patient.

Asthma is a long-term condition that affects the airways. When a person with asthma comes into contact with something that irritates their sensitive airways it causes the body to react in several ways which can include wheezing, coughing and can make breathing more difficult.

The NIHR Leicester Respiratory Biomedical Research Unit - a partnership between the University of Leicester and Leicester's Hospitals - focuses on promoting the development of new and effective therapies for the treatment of respiratory diseases including severe asthma and chronic obstructive pulmonary disease (COPD).

AirPROM stands for 'Airway Disease Predicting Outcomes through Patient Specific Computational Modelling'.

This is the technical name for the five year Europe-wide, EU funded project, which aimed to produce computer and physical models of the whole human airway system for people with asthma and chronic obstructive pulmonary disease (COPD).

AirPROM has demonstrated how an integrated approach, involving modelling, measurement and clinical validation, can accelerate the development of new therapies and improve existing methods.

Wednesday, May 10, 2017

New Antibiotic Discovered in the Nose

German researchers analyzed germs that inhabit the human body and found that about 30 percent of people had Staphylococcus aureus bacteria in their noses, but 70 percent did not, the Associated Press reported.
Those without S. aureus have another type of bacteria -- Staphyloccus lugdunensis -- in the nose that produces an antibiotic that keeps S. aureus in check, according to the study published online in the journal Nature.
Lugdunin is an antibiotic compound, a thiazolidine-containing cyclic peptide. It was isolated in 2016 after Staphylococcus lugdunensis was identified as the species of bacteria from the human nose that suppressed growth of species of disease-causing bacteria in that part of the humanmicrobiome. 
Ludgunin is a non-ribosomally synthesized cyclic peptide that inhibits growth of Staphylococcus aureus strain. The lugdunin genes are located on a 30-kbp operon. The genes lugA, lugB, lugC, and lugD encode four non-ribosomal peptide synthases, which are preceded by a putative regulator gene lugR
Lugdunin.svg
The scientists isolated this antibiotic, which they call lugdunin, and found that it was effective in treating mice whose skin was infected with S. aureus, the AP reported.
Lugdunin may offer a new way to fight antibiotic-resistant staph bacteria, one of the superbugs that pose a major health threat worldwide. Tests of lugdunin in humans have yet to be conducted.

Tuesday, May 9, 2017

FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu

In continuation of my update on tamiflu oseltamivir phosphate
U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999.
Oseltamivir.svg

The FDA is committed to improving patient access to safe and effective generic drugs. Generic drugs approved by the FDA have the same high-quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
The most common side effects reported by people using oseltamivir phosphate in clinical trials included nausea and vomiting.
Patients must use oseltamivir phosphate as directed by their health care provider. Oseltamivir phosphate does not take the place of receiving a flu vaccination. Talk to your health care provider about when you should receive an annual flu vaccination.
Oseltamivir phosphate does not treat or prevent illness caused by infections other than the influenza virus, and oseltamivir phosphate does not prevent bacterial infections that may happen with the flu. The FDA does not know if oseltamivir phosphate is effective in people who start treatment after two days of developing symptoms, or have weakened immune systems.
Patients and health care providers may find more information on oseltamivir phosphate in the drug label.

Monday, May 8, 2017

FDA Approves Flonase Sensimist Allergy Relief

Fluticasone furoate.svg
In continuation of my update on fluticasone

GSK Consumer Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter (OTC) treatment for symptoms associated with seasonal and perennial allergies. Previously available by prescription as Veramyst®, Flonase Sensimist is the latest Rx-to-OTC switch from GSK.
Flonase Sensimist helps block six allergic substances*, providing non-drowsy, 24-hour relief of both nose- and eye-related allergy symptoms like itchy, watery eyes**, nasal congestion, runny nose, itchy nose and sneezing.
“There are roughly 50 million people in the United States who suffer from allergies,2 and, as a category leader, GSK continues to innovate to satisfy the needs of all allergy sufferers,” said Amardeep Kahlon, Director of Marketing. “In the case of Flonase Sensimist, GSK is proud to offer an additional treatment option that not only provides more complete allergy symptom relief1 but also suits specific consumer preferences.”
Additional key features of Flonase Sensimist include:
  • Nasal allergy relief indicated for adults and children ages 2 and older**
  • Scent-free
  • Alcohol-free
  • Little or no drip
Flonase Sensimist will be nationally available OTC in early 2017.

About Flonase Sensimist

Flonase Sensimist (fluticasone furoate, 27.5 mcg spray) is an approved over-the-counter treatment for symptoms associated with seasonal and perennial allergic rhinitis including sneezing, runny nose, itchy nose, congestion, and itchy, watery eyes.**

FDA Approves Qbrelis (lisinopril) Oral Solution for Pediatric Patients 6 Years of Age and Older

We know that,  Lisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class used primarily in treatment of high blood pressure, heart failure, and after heart attacks. It is also used for preventing kidney and eye complications in people with diabetes. Its indications,contraindications, and side effects are as those for all ACE inhibitors.
Lisinopril was the third ACE inhibitor (after captopril and enalapril) and was introduced into therapy in the early 1990s. A number of properties distinguish it from other ACE inhibitors: It ishydrophilic, has a long half-life and tissue penetration, and is not metabolized by the liver.

Structural formula of lisinopril

Now Silvergate Pharmaceuticals, Inc., leader in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Qbrelis (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults. 

“We are excited to launch our second product focused on pediatric patients and pediatric hypertension” said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. “Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.”
Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose. Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service. For additional information on how to obtain Qbrelis, please call 1-855-379-0382.

About Qbrelis

Qbrelis delivers the trusted efficacy of lisinopril (an ACE inhibitor), the effectiveness of which has been well established in clinical trials.1 As a unique formulation of an oral solution, Qbrelis provides consistent potency and stability in each dose1, in addition to the quality of a product made in accordance with FDA regulations and requirements. People who have trouble swallowing lisinopril tablets may also benefit from Qbrelis.
Qbrelis reduces blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of a comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
More info @ https://www.drugs.com/history/qbrelis.html

Thursday, May 4, 2017

Lisinopril oral solution approved for treatment of hypertension in children and adults

Silvergate Pharmaceuticals, Inc.  leader in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Qbrelis™ (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis™ is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.

Structural formula of lisinopril

"We are excited to launch our second product focused on pediatric patients and pediatric hypertension" said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose. Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service.

Lisinopril oral solution approved for treatment of hypertension in children and adults

Silvergate Pharmaceuticals, Inc.  leader in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Qbrelis™ (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis™ is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.

Structural formula of lisinopril

"We are excited to launch our second product focused on pediatric patients and pediatric hypertension" said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. "Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."

Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose. Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service.

Wednesday, May 3, 2017

FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults


In continuation of my update on empagliflozin and metformin
The U.S. Food and Drug Administration has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). Synjardy, from Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both empagliflozin and metformin is appropriate.
Empagliflozin.svgempagliflozin Metformin.svgMetformin

Synjardy is a combination of empagliflozin (Jardiance) and metformin — two medicines with complementary mechanisms of action — to help control blood glucose in adults with T2D. Empagliflozin, a sodium glucose co-transporter-2 inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.
"Type 2 diabetes is a complex condition, which often requires that people take more than one treatment to manage their blood sugar," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "The expanded indication for Synjardy further validates the potential of this combination therapy to help adults with type 2 diabetes who are not at goal, including those already being treated and, now, those at the beginning of their treatment journey."
The Synjardy label was updated to include results from a phase III, double-blind, randomized, active-controlled study that evaluated the efficacy and safety of empagliflozin in combination with metformin as initial therapy compared with the individual components. In the study, at 24 weeks, the combination of empagliflozin 10 mg or 25 mg with metformin 1000 mg or 2000 mg resulted in significant reductions in A1C (a measure of average blood glucose over the past two to three months) compared with the corresponding dose of either component alone.
Synjardy can cause serious side effects, including Lactic Acidosis (a buildup of lactic acid in the blood). Metformin, one of the medicines in Synjardy, can cause lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Synjardy is not for the treatment of type 1 diabetes or diabetic ketoacidosis.

Tuesday, May 2, 2017

Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes

Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.
"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled."
The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA's request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting.
Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On Day 15, patients will increase dosage to 20 micrograms once daily.
Adlyxin is approved under the proprietary name, Lyxumia® in more than 60 countries and marketed in over 40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com.

About Adlyxin

Adlyxin is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise. GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.

AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C


In continuation of my update on Dasabuvir ombitasvir, paritaprevir and ritonavir
 AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). Viekira XR is not for people with decompensated cirrhosis.
Dasabuvir.svg dasabuvir  Ombitasvir.svg  ombitasvir

Paritaprevir structure 2.svgParitaprevir  Ritonavir structure.svgritonavir


Viekira XR is the first co-formulated three direct-acting antiviral (DAA) treatment for adult patients with GT1 HCV. Viekira XR is given once-daily as three oral tablets and must be taken with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients. The approval is supported by Phase 3 clinical trials for Viekira Pak which include data that demonstrated 100 percent sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95 percent SVR12 in GT1a patients when used with ribavirin for 12 or 24 weeks of therapy.
"AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. "The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the U.S. with clinical trial data using the components of Viekira XR demonstrating 100 percent cure rates in genotype 1b patients."
There are six major HCV genotypes (GT1-6) and GT1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases.1 Hepatitis C continues to be an important public health issue, with the Centers for Disease Control and Prevention (CDC) estimating that in the U.S. approximately 2.7 million people are chronically infected with HCV.2
The approval of Viekira XR is supported by data from seven Phase 3 clinical trials in more than 2,300 patients who received Viekira Pak with or without RBV for 12 or 24 weeks and two bioavailability studies comparing the formulations.

About Clinical Studies

The components of Viekira XR (administered twice daily with a meal) have been studied in seven Phase 3 clinical trials where 1076 subjects (including 181 with compensated cirrhosis) received the recommended regimen of Viekira +/? RBV for 12 weeks, or for 24 weeks in GT1a patients with compensated cirrhosis. Ninety-five to 100 percent achieved SVR12, which means the hepatitis C virus is not detectable in the blood three months after treatment ends. Cure rates varied by the subtype of hepatitis C and whether or not the person had cirrhosis. Individual results may vary.
USE
Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets/Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) (Viekira) are prescription medicines used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection.
Viekira can be used in people who have compensated cirrhosis.
Viekira is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking Viekira.

About Viekira XR

The components of Viekira XR* have been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naïve to difficult to treat patients, such as those with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV).
The extended-release co-formulation of these components, Viekira XR, consists of 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir per tablet, and is dosed three tablets once daily. Viekira XR must be taken with a meal, and tablets should be swallowed whole. People should not drink alcohol within four hours of taking Viekira XR. Viekira XR is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity. Viekira XR is taken for 12 weeks, except in GT1a patients with cirrhosis and all liver transplant recipients with normal hepatic function and mild fibrosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients and in all patients who have received a liver transplant.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is used in combination with AbbVie's ombitasvir with or without dasabuvir for the treatment of hepatitis C.
*Given as a fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal.