FDA Approves Ozempic
Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
December 5, 2017 -- 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.1
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.
About Ozempic (semaglutide)
Ozempic (semaglutide) injection 0.5 mg or 1 mg was approved by the FDA in December 2017, and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 Ozempic is an analog of native human glucagon-like peptide-1 (GLP-1) and, through its high albumin binding resulting in a long half-life of approximately one week, Ozempic is suitable for once-weekly dosing.1 Ozempic, administered once-weekly, stimulates insulin and lowers glucagon secretion in a glucose-dependent manner.1
About Type 2 Diabetes
Type 2 diabetes is a serious condition that affects more than 28 million people in the United States (9.4 percent of the population).2 The diagnosis is most common in adults and occurs when the body no longer produces enough of the blood sugar-regulating hormone, insulin, or is no longer able to use the insulin the body produces properly. Additionally, people with type 2 diabetes are two to four times more likely to have cardiovascular disease than those without diabetes.3 Type 2 diabetes is a life-long condition once diagnosed, but can be managed through a combination of lifestyle modifications like eating healthy, physical activity and oral and/or injectable medications as prescribed by a physician.4
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
2 Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Updated 2017. Accessed November 2017.
3 World Heart Federation. Risk Factors. https://www.world-heart-federation.org/resources/risk-factors/. Updated 2017. Accessed November 2017.
4 Centers for Disease Control and Prevention. Type 2 Diabetes. https://www.cdc.gov/diabetes/basics/type2.html. Updated July 25, 2017. Accessed November 2017.
Source: Novo Nordisk
Posted: December 2017
- Novo Nordisk Receives Positive 16-0 vote from FDA Advisory Committee in Favor of Approval for Semaglutide - October 18, 2017
- Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes - December 5, 2016
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