FDA approved Foundayo on April 1

The Food and Drug Administration approved Eli Lilly’s Foundayo on April 1, putting a daily weight-loss pill into the U.S. obesity market. (fda.gov) Foundayo is Lilly’s brand name for orforglipron, a glucagon-like peptide-1 drug that helps people feel fuller and eat less. The approval covers adults with obesity or overweight plus at least one weight-related medical problem. (fda.gov) (accessdata.fda.gov) The FDA said it issued the decision 50 days after Lilly filed the application and 294 days before the drug’s January 20, 2027 Prescription Drug User Fee Act target date. The agency called it the fastest approval of a new molecular entity since 2002. (fda.gov) In Lilly’s ATTAIN-1 trial, adults taking the highest dose lost an average of 27 pounds, according to the company. Lilly also said Foundayo can be taken any time of day without food or water restrictions. (investor.lilly.com) That convenience is the change. For years, the biggest obesity drugs were weekly injections, and the pill version could reach patients who avoided shots or never started treatment. (fda.gov) (investor.lilly.com) Foundayo is not arriving alone. FDA records show Wegovy tablets, an oral semaglutide product from Novo Nordisk, were also approved in 2025 for long-term weight reduction and cardiovascular risk reduction in some adults. (accessdata.fda.gov 1) (accessdata.fda.gov 2) The labels for Wegovy tablets and Foundayo both carry a boxed warning about thyroid C-cell tumors seen in rodents. Wegovy’s label also lists common side effects including nausea, vomiting, diarrhea, abdominal pain, headache, fatigue, dizziness, bloating, belching, low blood sugar in some patients with diabetes, and gas. (accessdata.fda.gov 1) (accessdata.fda.gov 2) Patient demand is already colliding with those warnings. A South Florida Sun Sentinel report published April 25 described people who reported rapid weight loss and other benefits while doctors urged medical supervision and closer attention to side effects and long-term use. (cbs12.com) (orlandosentinel.com) Lilly said on April 9 that Foundayo had already become available through LillyDirect, telehealth providers, and retail pharmacies nationwide. The company said prices start at $25 a month for some commercially insured patients and $149 a month for self-pay. (investor.lilly.com) The opening phase of the pill market is now set: two oral GLP-1 obesity drugs, one approved on December 23, 2025 and one on April 1, 2026, with access likely to widen faster than injection-only treatment did. (accessdata.fda.gov) (fda.gov)