Overview
- The approval covers chronic weight management and reducing major cardiovascular events in adults with obesity and established cardiovascular disease.
- In the 64-week OASIS-4 trial, adherent participants lost about 16–17% of body weight on average versus roughly 2–3% with placebo, and 76% achieved at least 5% loss.
- The once-daily semaglutide tablet targets a 25 mg maintenance dose and must be taken on an empty stomach with a small amount of water, followed by a 30-minute wait before food, drink, or other medicines.
- Novo Nordisk plans U.S. availability in January 2026 and set a $149 monthly price for the 1.5 mg starter dose for cash payers, with higher-dose pricing and insurer coverage still to be detailed.
- Gastrointestinal effects were the most common adverse events, and the FDA maintains a thyroid tumor warning with contraindications in medullary thyroid carcinoma and MEN2, while Eli Lilly’s oral orforglipron remains under FDA review.