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Product approval

Novo Nordisk gains FDA approval of Ozempic for T2DM

Treatment with Ozempic resulted in statistically significant reductions in body weight

Novo Nordisk has received FDA approval of Ozempic (semaglutide injection) that is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. Ozempic, the approved brand name for once-weekly semaglutide in the US, is a glucagon-like peptide 1 (GLP-1) receptor agonist. The approval of Ozempic is based on the results from the SUSTAIN clinical trial programme, comprising 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.

In people with type 2 diabetes, Ozempic produced clinically meaningful and statistically significant reductions in HbA1c compared with placebo, sitagliptin, exenatide extended-release and insulin glargine U100.

Furthermore, in the trials, treatment with Ozempic resulted in statistically significant reductions in body weight. Ozempic demonstrated a safe and well-tolerated profile across the SUSTAIN programme with the most common adverse event being mild to moderate nausea, which diminished over time.

"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 Dr Helena Rodbard, 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."

Ozempic is approved for use in two therapeutic dosages, 0.5mg and 1mg, and will be launched in the Ozempic Pen, the latest generation of Novo Nordisk prefilled devices. Novo Nordisk will, as part of the post-approval requirements, conduct a paediatric trial in adolescents under 18 years of age and will add Ozempic to the 15-year MTC (medullary thyroid carcinoma) registry that is being conducted for all other long-acting GLP-1 products.   

"We are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the US with type 2 diabetes in the beginning of 2018," said Mads Krogsgaard Thomsen, executive vice president and chief science officer. "Type 2 diabetes is a complex disease, but with the unique clinical profile of Ozempic, we believe it has the potential to set a new standard for the treatment of the disease."

Novo Nordisk expects to launch Ozempic in the US in Q1 2018, with a goal of ensuring broad insurance coverage and patient access to the product. The company revealed that Ozempic will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card programme 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.

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