Ozempic filed with FDA for risk reduction in MACE
Novo Nordisk has filed a supplemental NDA (sNDA) with the FDA for once-weekly Ozempic (semaglutide) injection 0.5 mg or 1 mg. The company is pursuing an indication to reduce the risk of MACE such as heart attack, stroke, or death in adults with type 2 diabetes and established CVD. The Ozempic sNDA has an anticipated 10-month review time. Ozempic was FDA approved on Dec 5, 2017 for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.
The application for the Ozempic cardiovascular risk reduction indication is based on the results of a cardiovascular outcomes trial examining the effects of adding semaglutide or placebo to standard of care on the risk of MACE in adults with type 2 diabetes and established CVD; SUSTAIN 6.
Comment: SUSTAIN 6 was an event- and time-driven, pre-approval CVOT for Ozempic. It was a randomized, double-blinded, placebo-controlled trial evaluating the cardiovascular safety of Ozempic vs placebo when added to standard of care in 3,297 adults with type 2 diabetes with established CVD or high risk of cardiovascular events.
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