The FDA has approved semaglutide injection 0.5 mg or 1 mg (Ozempic, Novo Nordisk), 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. The medication 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 is based on the results from a phase 3a clinical trial program. In people with type-2 diabetes, semaglutide injection showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin, and exenatide extended-release. As a secondary endpoint in the trials, treatment with semaglutide injection resulted in reductions in body weight. The most common adverse reactions reported in at least 5% of patients treated with semaglutide injection are nausea, vomiting, diarrhea, abdominal pain, and constipation.
Semaglutide injection is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen.
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.
Novo Nordisk expects to launch Ozempic in the U.S. in the first quarter of 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 copays 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.
Source: Novo Nordisk; December 5, 2017.