FDA Fast-Tracks Eli Lilly Foundayo Obesity Pill Approval
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The FDA fast‑tracked approval of Eli Lilly’s oral obesity pill Foundayo (generic orforglipron), completing review in 50 days under a new expedited program; the GLP‑1 pill mimics natural appetite hormones and produced a mean 11.2% weight loss (~25 lbs) at 36 mg over more than 16 months versus 2.1% for placebo in trial data, though 5–10% of patients discontinued for GI side effects versus nearly 3% on placebo. Foundayo can be taken without fasting or timing restrictions (unlike Novo Nordisk’s oral Wegovy), will be included in a Trump administration deal to lower GLP‑1 prices, and is priced in the U.S. at $149–$349 per month with insured patients potentially paying about $25/month via a Lilly discount card; Eli Lilly shares rose more than 4% after the approval. The decision arrives amid strong demand for GLP‑1s—more than 600,000 prescriptions for oral Wegovy have been written since December and about 1 in 8 Americans report using injectable GLP‑1 drugs.