NOVO — Wegovy FDA Review (NDA/BLA 215256, 2024)

Report summary

The FDA approved Wegovy (semaglutide) on March 8, 2024, for new indications: reducing major adverse cardiovascular events (MACE) in adults with established cardiovascular disease and for long-term weight management in adults and pediatric patients (12+) with obesity or overweight with comorbidities. The approval is based on the SELECT trial (NDA 215256 S11), which demonstrated a significant reduction in MACE, including cardiovascular death, nonfatal MI, and nonfatal stroke, in patients with overweight/obesity and established CV disease but without diabetes. Wegovy's clinical pharmacology, pharmacokinetics, and efficacy in weight reduction and cardiometabolic improvements were detailed. Safety information includes adverse reactions like gastrointestinal issues (leading to higher discontinuation rates), hypersensitivity, and diabetic retinopathy complications. While overall serious adverse events were comparable, gastrointestinal disorders were more frequent with semaglutide. The drug's benefit-risk profile was deemed favorable, with labeling addressing safety concerns. No medication errors were identified during the review.

Key findings — cited to the page