FDA Fast-Tracks Eli Lilly Foundayo Obesity Pill Approval
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The FDA has granted speedy approval to Eli Lilly’s oral GLP‑1 obesity pill Foundayo (generic orforglipron), completing its review in 50 days under a new expedited program; a pivotal NEJM trial found a mean 11.2% weight loss at 36 mg over more than 16 months (~25 lbs) versus 2.1% on placebo, with 5–10% discontinuing for gastrointestinal side effects versus nearly 3% for placebo. Foundayo is priced at $149–$349 per month (insured patients may pay about $25/month with a Lilly discount card), will be included in a federal effort to lower GLP‑1 prices, allows dosing without fasting or timing restrictions (unlike Novo Nordisk’s oral Wegovy, which has had 600,000+ prescriptions), and prompted a >4% rise in Lilly’s stock after the approval.