Ozempic OK’d for Reducing Major Cardio Events

FDA has approved a new indication for Novo Nordisk’s Ozempic (semaglutide) injection 0.5 mg or 1 mg — reducing 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 indication’s approval is based on results from the SUSTAIN 6 cardiovascular outcomes trial which examined the cardiovascular safety of adding Ozempic or placebo to standard of care in adults with Type 2 diabetes and established cardiovascular disease. Data showed that 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 company says.

During the trial, gastrointestinal adverse events were more frequent in the Ozempic group than in the placebo group, the company says. The majority of gastrointestinal adverse events occurred during the first 30 weeks.