Novo Nordisk announced that the Food and Drug Administration (FDA) has approved Ozempic (semaglutide) injection as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist. The FDA approval was supported by data from the SUSTAIN clinical program (8 Phase 3a trials; n>8,000) and a positive recommendation from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee in October 2017. Treatment with Ozempic resulted in clinically meaningful and statistically significant reductions in HbA1c vs placebo, sitagliptin, exenatide extended-release, and insulin glargine U100.
In addition, treatment with Ozempic resulted in statistically significant decreases in body weight. The most common adverse events reported were nausea. vomiting, diarrhea, abdominal pain, and constipation.
In accordance with the post-approval requirements, Novo Nordisk will conduct a pediatric study in patients <18 years old and will add Ozempic to the 15-year medullary thyroid carcinoma (MTC) registry being conducted for other long-acting GLP-1 agonists.
Ozempic will be available as 0.5mg and 1mg strength pens. It is administered once weekly, on the same day each week, with or without meals.
The product is anticipated to launch in the beginning of 2018.
Novo Nordisk receives FDA approval of OZEMPIC® (semaglutide) injection for the treatment of adults with type 2 diabetes [press release]. Plainsboro, New Jersey: Novo Nordisk USA. http://press.novonordisk-us.com/2017-12-5-Novo-Nordisk-Receives-FDA-Approval-of-OZEMPIC-R-semaglutide-Injection-For-the-Treatment-of-Adults-with-Type-2-Diabetes. Accessed December 5, 2017.
This article originally appeared on MPR