FDA approves Ozempic for type 2 diabetes + CV risks.- Novo Nordisk

Novo Nordisk announced that the FDA has approved a new indication for Ozempic (semaglutide) 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 FDA's decision on Ozempic is based on results from the SUSTAIN 6 cardiovascular outcomes trial (CVOT) which examined the cardiovascular safety of adding Ozempic or placebo to standard of care in adults with type 2 diabetes and established cardiovascular disease. In the 2-year SUSTAIN 6 trial, 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 estimated relative risk reduction of MACE was 26% vs placebo (HR 0.74 [95% CI: 0.58, 0.95], p<0.001 for noninferiority, median observation time 2.1 years) with the primary composite outcome occurring in 6.6% of patients treated with ozempic vs 8.9% with placebo. during the trial, gastrointestinal adverse events were more frequent in the ozempic group than in the placebo group. the majority of gastrointestinal adverse events occurred during the first 30 weeks. additional details were added to the rybelsus (semaglutide) tablets 7 mg or 14 mg prescribing information about the primary analysis for pioneer 6.>