Overview
- The approval covers adults who are obese or overweight with at least one weight‑related condition, making it the first U.S. clearance for an oral GLP‑1 specifically for weight control.
- The label also includes reducing the risk of major cardiovascular events in patients with established cardiovascular disease who are overweight or obese.
- Phase 3 data, including OASIS 4, showed mean weight loss around 16.6% versus about 2.7% with placebo, with class‑typical gastrointestinal side effects such as nausea, vomiting, and diarrhea.
- The once‑daily pill must be taken on an empty stomach with limited water, a requirement that could challenge adherence despite avoiding injections.
- Novo Nordisk shares rose roughly 9% on the approval, while payer coverage and Eli Lilly’s FDA‑filed oral rival orforglipron remain key factors for market uptake.