Posted by Michael Wonder on 06 Dec 2017
Ozempic (semaglutide) approved in the US
5 December 2017 - Novo Nordisk today announced that the US FDA has approved Ozempic (semaglutide injection).
Ozempic 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 and follows a positive recommendation from an FDA Advisory Committee meeting on 18 October 2017. 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.
