FDA: Semaglutide Approval for Adults With T2D
The efficacy of semaglutide was examined in more than 8000 adults with type 2 diabetes.
The US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide; Novo Nordisk) injection to treat adults with type 2 diabetes.1
The once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist showed “clinically meaningful and statistically significant” HbA1c reductions in study participants vs placebo, sitagliptin, and exenatide extended release. The phase 3a clinical trial program (SUSTAIN™; NCT02054897, NCT01930188, NCT01885208, NCT02128932, NCT02305381, and NCT01720446) involved more than 8000 adults with type 2 diabetes and included an outcomes trial examining cardiovascular safety.2
“The approval of semaglutide offers healthcare professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals,” said Helena Rodbard, MD, FACP, MACE, medical director of Endocrine and Metabolic Consultants in Rockville, MD, in a press release.1
Used in conjunction with diet and exercise, Ozempic is administered once weekly. It is expected to launch in early 2018 and will be available in 0.5-mg and 1-mg doses delivered via prefilled pen.
Possible Ozempic side effects include thyroid tumors, pancreatitis, hypoglycemia, or kidney failure. Ozempic is not intended for use in people with type 1 diabetes.
- Novo Nordisk receives FDA approval of Ozempic® (semaglutide) injection for the treatment of adults with type 2 diabetes [news release]. Plainsboro, NJ: Novo Nordisk Inc. 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. Published December 5, 2017. Accessed December 5, 2017.
- OZEMPIC® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2017.