Overview
- The decision authorizes the first oral GLP-1 for chronic weight management in adults with obesity or overweight plus a related condition.
- Novo Nordisk says U.S. availability begins in January, with a self-pay starting dose priced at $149 under a White House agreement.
- A 64-week trial showed average weight loss of 16.6% on the 25 mg tablet, or about 13.6% with typical adherence, versus roughly 2% on placebo.
- Dosing requires an empty stomach with a small amount of water and a 30-minute wait before food or other medicines, and gastrointestinal side effects were common with about 7% discontinuing due to adverse events.
- Eli Lilly’s competing oral candidate, orforglipron, remains under FDA review with low‑teens weight loss and no food or water restrictions in trials, as analysts estimate pills could capture around 20% of the market by 2030.