Benzodiazepines linked to increased risk of death among Alzheimer’s disease patients

Benzodiazepine and related drug use is associated with a 40 per cent increase in mortality among persons with Alzheimer's disease, according to a new study from the University of Eastern Finland. The findings were published in the International Journal of Geriatric Psychiatry.

The study found that the risk of death was increased right from the initiation of benzodiazepine and related drug use. The increased risk of death may result from the adverse events of these drugs, including fall-related injuries, such as hip fractures, as well as pneumonia and stroke.

The study was based on the register-based MEDALZ (Medication Use and Alzheimer's Disease) cohort, which includes all persons diagnosed with Alzheimer's disease in Finland during 2005-2011. Persons who had used benzodiazepines and related drugs previously were excluded from this study, and therefore, the study population consisted of 10,380 new users of these drugs. They were compared with 20,760 persons who did not use these drugs.

Although several treatment guidelines state that non-pharmacological options are the first-line treatment of anxiety, agitation and insomnia in persons with dementia, benzodiazepines and related drugs are frequently used in the treatment of these symptoms. If benzodiazepine and related drug use is necessary, these drugs are recommended for short-term use only. These new results encourage more consideration for benzodiazepine and related drug use in persons with dementia.

Ref : https://www.uef.fi/en/-/bentsodiatsepiinit-lisaavat-kuolleisuutta-alzheimerin-tautia-sairastavilla

Benzodiazepines linked to increased risk of death among Alzheimer’s disease patients

Moderate coffee consumption more likely to provide beneficial health outcomes

In continuation of my update on coffee

Drinking coffee is "more likely to benefit health than to harm it" for a range of health outcomes, say researchers in The BMJ today.

They bring together evidence from over 200 studies and find that drinking three to four cups of coffee a day is associated with a lower risk of death and getting heart disease compared with drinking no coffee. Coffee drinking is also associated with lower risk of some cancers, diabetes, liver disease and dementia.

However, they say drinking coffee in pregnancy may be associated with harms, and may be linked to a very small increased risk of fracture in women.

The included studies used mainly observational data, providing lower quality evidence, so no firm conclusions can be drawn about cause and effect, but their findings back up other recent reviews and studies of coffee intake. As such, they say, excluding pregnancy and women at risk of fracture, "coffee drinking appears safe within usual patterns of consumption" and they suggest that coffee could be safely tested in randomised trials.

Coffee is one of the most commonly consumed beverages worldwide and could have positive health benefits. But existing evidence is of lower quality from observational research and randomized controlled trials are needed to strengthen the evidence of benefits.

To better understand the effects of coffee consumption on health, a team led by Dr Robin Poole, Specialist Registrar in Public Health at the University of Southampton, with collaborators from the University of Edinburgh, carried out an umbrella review of 201 studies that had aggregated data from observational research and 17 studies that had aggregated data from clinical trials across all countries and all settings.

Umbrella reviews synthesize previous meta-analyses and provide a high-level summary of research on a particular topic

Drinking coffee was consistently associated with a lower risk of death from all causes and from heart disease, with the largest reduction in relative risk of death at three cups a day, compared with non-coffee drinkers. Increasing consumption to above three cups a day was not associated with harm, but the beneficial effect was less pronounced.

Coffee was also associated with a lower risk of several cancers, including prostate, endometrial, skin and liver cancer, as well as type 2 diabetes, gallstones and gout. The greatest benefit was seen for liver conditions, such as cirrhosis of the liver.

Finally, there seemed to be beneficial associations between coffee consumption and Parkinson's disease, depression and Alzheimer's disease.

There was less evidence for the effects of drinking decaffeinated coffee but it had similar benefits for a number of outcomes.

Many of the included studies may have adjusted for factors that may be associated with both the health outcome and with coffee drinking, such as smoking. This was not comprehensive and varied from study to study. The authors can therefore not rule out the effect of such factors on the apparent harmful or beneficial associations.

The authors conclude that coffee drinking "seems safe within usual patterns of consumption, except during pregnancy and in women at increased risk of fracture." And they call for robust randomized controlled trials "to understand whether the key observed associations are causal."

In a linked editorial, Eliseo Guallar at the Johns Hopkins Bloomberg School of Public Health says, although we can be reassured that coffee intake is generally safe, doctors should not recommend drinking coffee to prevent disease - and people should not start drinking coffee for health reasons.

As this study shows, some people may be at higher risk of adverse effects, he writes, and there is "substantial uncertainty" about the effects of higher levels of intake. Finally, coffee is often consumed with products rich in refined sugars and unhealthy fats, "and these may independently contribute to adverse health outcomes," he adds.

However, even with these caveats, "moderate coffee consumption seems remarkably safe, and it can be incorporated as part of a healthy diet by most of the adult population," he concludes.

Ref : http://www.bmj.com/content/359/bmj.j5356

Moderate coffee consumption more likely to provide beneficial health outcomes

FDA Expands Approval of Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

In continuation of my update on Sprycel(dasatinib)

Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel(dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted under priority review, and the indication received orphan drug designation from the FDA. The safety and efficacy of Sprycel in pediatric patients was evaluated in two pediatric studies of 97 patients with CP-CML: an open-label, non-randomized, dose-ranging trial (NCT00306202) and an open-label, non-randomized, single-arm trial (NCT00777036). Among the 97 patients in the two studies, 51 patients (exclusively from the single-arm trial) had newly diagnosed CP-CML, and 46 patients (17 from the dose-ranging trial and 29 from the single-arm trial) were resistant or intolerant to previous treatment with imatinib.

Sprycel is associated with the following Warnings and Precautions: myelosuppression, bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe dermatologic reactions, tumor lysis syndrome, embryo-fetal toxicity and effects on growth and development in pediatric patients.¹.

“While chronic myeloid leukemia is rare in children, accounting for less than three percent of all pediatric leukemias, it is often more aggressive in younger patients than in adults and until recently, there have been few available treatment options,”^2,3 said Vickie Buenger, President, Coalition Against Childhood Cancer. “The FDA’s decision to approve the expanded use of Sprycel in children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase may bring new hope to these patients and their families.”

“Our decision to pursue an expanded indication for Sprycel is indicative of our commitment to exploring pediatric applications within our broad development program,” said Johanna Mercier, head, U.S. Commercial, Bristol-Myers Squibb. “We are pleased this option is now available for appropriate pediatric chronic phase CML patients and their physicians.”

As part of its commitment to children and adolescents with cancer, Bristol-Myers Squibb continues to explore pediatric applications for investigational oncology agents within its broad development program. In addition, Bristol-Myers Squibb supports organizations and initiatives focused on pediatric patients and their families.

Fat-busting ingredients in cinnamon

In continuation of my update on Cinnamon...

Researchers have found that certain ingredients in cinnamon can help burn fat in humans. They along with several other previous studies have noted that cinnamon – a common kitchen spice – contains cinnamaldehyde. This is an essential oil that gives the special flavor to cinnamon. In laboratory mice, cinnamaldehyde helps to protect against obesity as has been seen in previous studies.

This new study from the team of researchers at the University of Michigan reports that this oil can burn fat in humans as well. The study titled, “Cinnamaldehyde induces fat cell-autonomous thermogenesis and metabolic reprogramming,” was published in the latest issue of the journal Metabolism.

The team found that this essential oil in cinnamon can activate thermogenesis. This means that it can activate the metabolism in the body that can burn the body fat to produce heat. There are several other metabolic benefits offered by cinnamon to the body. The gearing up of the metabolism also leads to starting off on a path to weight loss they explain. Lead author Jun Wu, research assistant professor at the Life Sciences Institute said that the benefits of cinnamaldehyde are a known one because of the studies that have been already conducted proving its effects on obesity. What was not known, Wu noted, was the effects cinnamaldehyde was having on metabolism. This was what prompted this study. Wu said, “…we wanted to figure out how -- what pathway might be involved, what it looked like in mice and what it looked like in human cells.”

For this objective Wu and colleagues tried to see the effects of cinnamaldehyde on several volunteers or participants who agreed to provide some of their body fat cells or tissues for laboratory studies. The volunteers had different body weights, and were of different or varied age groups and ethnicities. They found that use of this essential oil led to enhancement of certain genes in the adipocytes of fat cells. This led to increased lipid metabolism or break down of the fat. It also triggered thermogenesis or production of heat by breaking down the body fat. Till date however the team has tested this in human cells in the laboratory and not on humans as such.

Molecular look at the state of affairs showed that cinnamaldehyde could significantly activate “protein kinase A (PKA) signaling”. This caused increased workings of genes that can cause thermogenesis. This led to increased “HSL and PLIN1 in murine primary adipocytes.” There is an increased in genetic workings of proteins Ucp1 and Fgf21 which normally play a role in metabolism and its regulations. Dr. Wu explained that energy surplus and its storage in the adipocytes is a new phenomenon for humans with the abundance of food.

Wu explained that more studies on actual human subjects was necessary to prove that use of cinnamaldehyde indeed was beneficial and safe for consumption. Wu said he hopes that this spice that has been part of the human diet for centuries could offer protection against obesity that is becoming a rising epidemic worldwide. People generally enjoy this spice and if it is protective and beneficial, the chances that people would adopt this and stick to this therapy are higher.

Ref : http://www.metabolismjournal.com/article/S0026-0495(17)30212-3/fulltext

Fat-busting ingredients in cinnamon

Sunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD

In continuation of my update on glycopyrrolate

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sunovion expects Lonhala Magnair to be available in U.S. pharmacies in early 2018.

Lonhala Magnair is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the U.S. and the first use of the Magnair, which is based on the closed eFlow® technology system, developed by PARI Pharma GmbH, to treat COPD. This technology is a virtually silent, portable, closed system nebulizer that is designed to deliver the drug in two to three minutes and allows people to breathe normally while using the device.

“We are proud that the FDA has approved Lonhala Magnair as the first nebulized, long-acting muscarinic antagonist treatment option for people in the U.S. living with COPD,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “The approval of Lonhala Magnair underscores our leadership in nebulization and the value we place on providing innovative treatment options for people living with COPD. Lonhala Magnair is an important addition to our portfolio of approved COPD therapies for people at various stages of COPD, providing the flexibility to choose handheld or nebulized products based on individual needs.”

“Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication,” said Gary Ferguson, M.D., Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique handheld nebulizer that allows a person to breathe normally while taking their medication.”

Approximately 15.7 million adults in the U.S. report they have been diagnosed with COPD, a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases.^1,2 The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute.² The disease makes it hard for people to breathe and subsequently may limit their ability to perform some routine activities, including the proper inhalation of medication.² This improper medication technique may impact treatment over time and may also result in an inadequate amount of the drug reaching the lungs, potentially worsening a person’s COPD.^3,4,5 For people with moderate-to-very-severe COPD, nebulized treatments offer an alternative to inhalers, allowing a person to breathe normally while taking their medicine.

The approval is based on data from the clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) program, which included GOLDEN-3 and GOLDEN-4, two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing LONHALA MAGNAIR with placebo in adults with moderate-to-very-severe COPD. At study endpoints, individuals treated with Lonhala Magnair demonstrated statistically significant and clinically important changes from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 versus placebo. An additional study, GOLDEN-5, was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long-term safety and tolerability of Lonhala Magnair in adults with moderate-to-very-severe COPD and included the active comparator Spiriva® (tiotropium bromide) delivered by the HandiHaler® device. Lonhala Magnair was generally well-tolerated in clinical studies, with the most common side effects being exacerbations and cough. The overall treatment emergent adverse events (TEAE) incidences were similar for glycopyrrolate and tiotropium groups over 48 weeks.

Sunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD

Antimalarial drugs could find another use as cancer treatments, study says

Antimalarial drugs chloroquine and hydroxychloroquine could find another use as cancer treatments, according to a new clinical study published in ecancermedicalscience.

Researchers from the Repurposing Drugs in Oncology (ReDO) project, an international collaboration between the Anticancer Fund, Belgium, and USA-based GlobalCures, say there is evidence to include these drugs in further clinical investigations.

The authors are particularly excited about the potential for chloroquine and hydroxychloroquine as the evidence suggests they make tumor cells more sensitive to cancer treatment.
Chloroquine   Hydroxy chlroquine 

"What makes chloroquine and hydroxychloroquine so interesting is these multiple mechanisms of action", says Ciska Verbaanderd of the Anticancer Fund and the University of Leuven, Belgium, first author of the study."These antimalarial drugs act on both the level of cancer cells and the tumor microenvironment." Studying this has led to interesting scientific insights in tumor biology, such as the importance of autophagy, the tumor vasculature and the immune system."

"The results from the review lead us to believe that these antimalarial drugs could offer significant clinical benefit for certain cancer patients, especially in combination with standard anticancer treatments.This should be confirmed by additional clinical results."

Vikas P. Sukhatme MD ScD, co-founder of GlobalCures and one of the authors of this review, added "We look forward with much anticipation to the results of the 30 or so ongoing clinical studies that use chloroquine or hydroxychloroquine for cancer treatment."

The researchers' hope is that with the publication of this study, increased awareness of the potential applications will bring these medications out of the medicine cabinet - and into cancer care.

Previous papers from the ReDO project have explored how inexpensive, common drugs such as beta-blockers and anti-fungal remedies can be "repurposed" and used as part of cancer treatments.

Ref : http://ecancer.org/news/12864-antimalarial-drugs-could-support-existing-cancer-treatments-in-two-pronged-attack.php

Antimalarial drugs could find another use as cancer treatments, study says

Tesaro Announces U.S. FDA Approval of Varubi IV for Delayed Nausea and Vomiting Associated With Cancer Chemotherapy

In continuation of my update on Varubi (rolapitant)

Tesaro, Inc.  an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Varubi (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Delayed nausea and vomiting can occur anytime between 25 and 120 hours following chemotherapy, and is often extremely debilitating.

About Varubi

Varubi is a highly selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, which play an important role in the delayed phase of chemotherapy-induced nausea and vomiting (CINV). With a long plasma half-life of approximately seven days, a single dose of Varubi, as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of CINV. Results from three Phase 3 trials of Varubi oral tablets demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens. In addition, patients who received Varubi reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy. Results from a bioequivalence trial demonstrated comparability of the IV and oral formulations of Varubi.

Varubi IV is supplied in ready-to-use vials and does not require refrigerated storage or mixing. As a result, utilization in busy chemotherapy clinics is straightforward and easily adopted into existing practice patterns for administration of antiemetic regimens associated with emetogenic chemotherapy. Varubi IV is to be administered up to two hours before chemotherapy administration in combination with a 5-HT3 receptor antagonist and dexamethasone. No dosage adjustment is required for dexamethasone, a CYP3A4 substrate, and Varubi is the first intravenously administered NK-1 receptor antagonist approved by the FDA that does not contain polysorbate 80.

“The approval of Varubi IV represents a significant milestone for TESARO. The majority of NK-1 receptor antagonist doses are administered intravenously in the U.S., and with the introduction of Varubi IV, we now offer healthcare providers a unique, easy-to-use option that fits well into standard operating practices of a chemotherapy clinic or hospital,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “We will continue our efforts to expand awareness of delayed chemotherapy-induced nausea and vomiting, and plan to make this important medicine available next month.”

“Many healthcare providers tend to believe that CINV is no longer an unmet need but the reality is that more than half of patients treated with emetogenic chemotherapy experience delayed CINV, even when prescribed standard preventative therapies, such as a 5-HT3 receptor antagonist and dexamethasone,” said Lee Schwartzberg, M.D., Professor of Medicine at University of Tennessee Health Science Center. “The FDA approval of VARUBI IV gives doctors and nurses a new option to help protect their patients from these often preventable side effects.”

Tesaro Announces U.S. FDA Approval of Varubi IV for Delayed Nausea and Vomiting Associated With Cancer Chemotherapy

Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older

In continuation of my update on Tekturna (aliskiren)

Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic areas, announced today the approval by the U.S. Food and Drug Administration of Tekturna (aliskiren) Oral Pellets for the treatment of hypertension in adults and children six years of age and older. The new formulation and pediatric indication were approved through the FDA priority review process. Noden Pharma DAC.

"This expanded indication for Tekturna provides an additional option for pediatric hypertensive patients," said Alan Markey, acting CEO of Noden Pharma DAC. "In addition, it provides an alternative dosing option for adults with hypertension."

According to hypertension guidelines published by the American Academy of Pediatrics (AAP) the prevalence of clinical hypertension in children and adolescents is ~3.5%. The prevalence of persistently elevated blood pressure is ~2.2% to 3.5%, with higher rates among children and adolescents who are overweight and those with obesity.^1‍

The efficacy and safety of Tekturna® for pediatric use was evaluated in an 8-week randomized, double-blind trial in 267 hypertensive patients 6 to 17 years of age, including 208 patients treated for 52 weeks, following the 8-week study. During the initial dose-response phase, Tekturna® reduced both systolic and diastolic blood pressure in a weight-based dose-dependent manner. These studies did not reveal any unanticipated adverse reactions. Adverse reactions in pediatric patients six years of age and older are expected to be similar to those seen in adults.

Tekturna® Oral Pellets may be taken by carefully opening the dispensing capsule and emptying the contents into a spoon then into the mouth, and then swallowing right away with water or milk (dairy or soy-based) without chewing or crushing. Alternatively, the contents can be taken orally immediately after mixing with specified dosing vehicles.

John McLaughlin, CEO of PDL BioPharma, said, "Our investment in Noden has provided us with a platform upon which to build a specialty pharmaceutical company, and we are pleased to see the team at Noden execute this important expansion of the label for Tekturna®."

Noden plans to make Tekturna® Oral Pellets available in 2018.

Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older

Over-the-counter decongestant found to be effective inhibitor of tumor stroma

In continuation of my update on N-Acetyl cysteine  - or NAC

CANCER researchers seeking non-toxic alternatives to harmful chemotherapy are reporting a highly significant result for a humble cold remedy.

N-Acetyl cysteine  - or NAC - is routinely used as a dietary supplement and as a decongestant given to children to ward off a cold.

Now, clinical trials in the US indicate the cheap, over-the-counter drug, is a first rate inhibitor of the tumor stroma, a cell compartment which is fundamental to the spread of cancer.

The results, published in Seminars in Oncology, confirm a long-held theory that cancer cells are being sustained and strengthened by the presence of MCT4, a protein which 'brings them' energy, in the form of lactate, from neighboring cells.

Patients taking high dosages of NAC saw their levels of the 'transporter' protein fall by more than 80%, drastically reducing the ability of the cancer cells to feed off neighboring cells.

Professor Federica Sotgia, of the Biomedical Research Centre at the University of Salford, UK, explained: "In cell cultures in the laboratory, we had seen a near complete reduction in MCT4, but to achieve such a substantial result in breast cancer patients is extremely exciting indeed."

The team, which includes Professor Michael Lisanti, of the University of Salford and US-based Ubaldo Martinez-Outschoorn, MD, conducted a 'window trial' on 12 patients awaiting surgery for breast cancer at The Sidney Kimmel Cancer Center (Thomas Jefferson University), in Philadelphia.

Patients were given maximum daily dosages of the over-the-counter drug for three weeks between diagnosis and surgery. Tumor tissue biopsies were then taken before and during surgery and key biomarkers, including MCT4 and K167, were measured post-surgery.

K167 levels fell by 25% and MCT4 levels were reduced by approximately 80%.

"High levels of stromal MCT4 are extremely worrying, as they are linked to aggressive cancer behavior and poor overall survival, so this is very encouraging result," explained Professor Lisanti.

"Our idea was to repurpose an inexpensive FDA-approved drug, to examine if its antioxidant properties could target the feeding behavior of cancer cells.  To be able to inhibit MCT4 protein expression, in a non-toxic way, is huge step forward."

Over-the-counter decongestant found to be effective inhibitor of tumor stroma

Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.¹ Ozempic is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.

The approval of Ozempic is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, Ozempic showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.¹ As a secondary endpoint in the trials, treatment with Ozempic resulted in reductions in body weight. The most common adverse reactions reported in ≥5% of patients treated with Ozempic are: nausea, vomiting, diarrhea, abdominal pain and constipation.¹

"The Ozempic approval builds on Novo Nordisk's commitment to offering healthcare professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients' lifestyles," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "We are grateful to the many adults with type 2 diabetes who participated in the studies, as well as the clinical trial investigators. Thanks to their collective contributions, Novo Nordisk is able to bring once-weekly Ozempic to the type 2 diabetes community."

Ozempic is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen.¹

The global Phase 3a clinical trial program for Ozempic comprised eight clinical trials involving more than 8,000 adults with type 2 diabetes, including a two-year cardiovascular outcomes trial that evaluated safety in adults with type 2 diabetes at high risk of cardiovascular events.¹

"Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals," said Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, and past president of the American Association of Clinical Endocrinologists. "The approval of semaglutide offers healthcare professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals."

Novo Nordisk expects to launch Ozempic in the U.S. in Q1 2018, with a goal of ensuring broad insurance coverage and patient access to the product. Ozempic will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce co-pays for eligible commercially-insured patients. Additionally, as part of the access strategy, Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions.

Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes