Lilly wins FDA nod for oral GLP‑1 Foundayo

The Food and Drug Administration approved Eli Lilly’s once-daily obesity pill Foundayo on April 1, giving the weight-loss drug market a second oral contender in the United States. (fda.gov) Foundayo is the brand name for orforglipron, a glucagon-like peptide-1 receptor agonist cleared for adults with obesity, or adults with overweight plus at least one weight-related condition, alongside diet and exercise. The Food and Drug Administration said the decision came 50 days after filing and 294 days before the original January 20, 2027 target date. (fda.gov) Glucagon-like peptide-1 drugs mimic a gut hormone that helps people feel fuller and eat less. Lilly says Foundayo is taken by mouth once a day and, unlike some earlier oral drugs in the class, can be taken without food or water restrictions. (medical.lilly.com) The approval arrived less than three months after Novo Nordisk’s oral Wegovy reached the market, according to CNBC, turning the obesity-drug fight from injectable shots into a race between pills. Reuters reported the decision set up Lilly’s “next battle” with Novo Nordisk for patients seeking glucagon-like peptide-1 medicines. (cnbc.com) (reuters.com) In the phase 3 ATTAIN-1 trial, adults without diabetes who took the highest 36-milligram dose lost an average of 12.4% of body weight, or 27.3 pounds, at 72 weeks, Lilly said. A New England Journal of Medicine report on the trial said 3,127 patients were randomized across 6-milligram, 12-milligram, 36-milligram, and placebo groups. (prnewswire.com) (nejm.org) The Food and Drug Administration label carries a boxed warning about the risk of thyroid C-cell tumors and says Foundayo is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. The label also lists nausea, vomiting, diarrhea, constipation, indigestion, and stomach pain among common adverse reactions. (accessdata.fda.gov) Lilly said on April 9 that Foundayo had become available through LillyDirect and retail pharmacies nationwide. The company said the pill starts at $25 a month for commercially insured patients with coverage and $149 a month for self-pay patients. (prnewswire.com) The Food and Drug Administration also used the decision to highlight its National Priority Voucher pilot, saying Foundayo was the first new molecular entity approved under that program and the fastest approval of a new molecular entity since 2002. Lilly’s pill now enters a market where convenience, side effects, insurance coverage, and supply may matter as much as headline weight-loss numbers. (fda.gov)