Overview
- The approval covers a 25 milligram semaglutide tablet for chronic weight management in adults with obesity or overweight plus a related health condition.
- In late-stage trials, participants lost about 13.6% to 16.6% of body weight over roughly 64 weeks versus about 2% to 3% on placebo, with gastrointestinal side effects the most common and about 7% discontinuing.
- The pill must be taken first thing on an empty stomach with a small amount of water, followed by a 30-minute wait before food, drink or other medications, a regimen that could influence adherence and effectiveness.
- Novo Nordisk will offer the starting dose at $149 per month for self-pay patients under a November agreement with the Trump administration, while pricing for higher doses and insurance coverage details remain to be clarified.
- The decision gives Novo Nordisk a head start over Eli Lilly’s oral candidate orforglipron, which remains under FDA review, as Novo boosts U.S. manufacturing and notes oral formulations are generally easier to produce than injectables.