FDA Approves Once-Weekly Semaglutide for Type 2 Diabetes

The FDA has approved Novo Nordisk’s semaglutide injection (Ozempic), a glucagon-like peptide 1 (GLP-1) receptor agonist, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to a company statement.

The once-weekly semaglutide is approved for use in 2 therapeutic dosages: 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen. It should be administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.

Based on data from the SUSTAIN clinical trial program, the approval follows a positive recommendation from an FDA Advisory Committee meeting held on October 18, 2017. Panel members from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0, supporting recommendation for approval.

The trial program consisted of 8 phase 3a trials, including more than 8000 adults with type 2 diabetes, some with high cardiovascular risk profiles and those with and without renal disease, according to Novo Nordisk. In the trial, patients with type 2 diabetes taking the medication demonstrated clinically meaningful and statistically significant reductions in HbA1c, compared with a placebo, sitagliptin, exenatide extended-release, and insulin glargine U100.

Treatment with the drug also resulted in statistically significant reductions in body weight, according to the statement. Common adverse events associated with use included mild to moderate nausea, which diminished over time.

As part of post-approval requirements, Novo Nordisk will conduct a pediatric trial in children under 18 and will add Ozempic to the 15-year medullary thyroid carcinoma registry that is being conducted for all other long-acting GLP-1 products.

In the video below, Dhiren Patel, PharmD, talks about what semaglutide's approval means for diabetes care, including its cardiovascular data and potential indications for obesity.

Reference

Ozempic® (semaglutide) approved in the US [news release]. novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2154210.html. Published December 5, 2017. Accessed December 5, 2017.