Ozempic Approved for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes

January 28, 2020

Novo Nordisk’s Ozempic (semaglutide) received FDA approval for injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.

The approval was based on the results of a two-year clinical trial in which Ozempic significantly reduced the risk of the occurrence of a three-component MACE endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke.

The drug was originally approved in 2017 for glycemic control in adults with type 2 diabetes in conjunction with diet and exercise.

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