New diabetes drug Ozempic approved in the USA

6 December 2017

Following a positive advisory committee vote in October, the US Food and Drug Administration has now given its formal approval to allow the marketing of Ozempic (semaglutide injection) in the USA.

Danish diabetes care giant Novo Nordisk’s (NOV: N) Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. News of the US approval lifted Novo Nordisk’s share price 3.96% to 330.60 Danish kroner by afternoon trading today.

Ozempic, the approved brand name for once-weekly semaglutide in the USA, is a glucagon-like peptide 1 (GLP-1) receptor agonist. The approval of Ozempic is based on the results from the SUSTAIN clinical trial program. In people with type 2 diabetes, Ozempicproduced clinically-meaningful and statistically-significant reductions in HbA1c compared with placebo, sitagliptin, exenatide extended-release and insulin glargine U100.

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