Lilly launches oral GLP‑1

Eli Lilly has started shipping Foundayo, a once-daily weight-loss pill, days after the United States approved it on April 1. (fda.gov) (prnewswire.com) The Food and Drug Administration cleared Foundayo, also called orforglipron, for adults with obesity and for adults who are overweight and have at least one weight-related condition, alongside diet and exercise. The agency said the review took 50 days under its Commissioner’s National Priority Voucher pilot, 294 days ahead of the drug’s January 20, 2027 target date. (fda.gov) Foundayo is a glucagon-like peptide-1 receptor agonist, a class of drugs that helps people feel fuller and eat less. Lilly says this version can be taken once a day with or without food and without water restrictions, unlike earlier oral drugs that came with tighter dosing rules. (fda.gov) (foundayo.lilly.com) Lilly said on April 9 that Foundayo was available through LillyDirect, telehealth providers, and retail pharmacies, with home delivery through LillyDirect. The company said eligible commercially insured patients may pay as little as $25 a month, while self-pay pricing starts at $149 a month at the lowest dose. (prnewswire.com) (foundayo.lilly.com) The launch gives Lilly a pill to sell alongside its injectable obesity drug Zepbound as demand for weight-loss medicines keeps expanding. It also gives doctors a tablet option for patients who do not want weekly injections. (prnewswire.com) (foundayo.lilly.com) The label carries a boxed warning about thyroid C-cell tumors, and the drug is contraindicated for patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. The prescribing information also warns about pancreatitis, severe gastrointestinal reactions, kidney injury tied to dehydration, and hypoglycemia when used with insulin or certain diabetes drugs. (pi.lilly.com) Dosing starts at 0.8 milligrams once daily, then steps up after at least 30 days to 2.5 milligrams and then 5.5 milligrams, with optional increases to 9 milligrams, 14.5 milligrams, and 17.2 milligrams based on response and tolerability. The maximum dose is 17.2 milligrams once daily. (pi.lilly.com) (fda.gov) In Lilly’s ATTAIN-1 trial, the company said people who stayed on the highest dose lost an average of 27.3 pounds, or 12.4% of body weight, versus 2.2 pounds, or 0.9%, on placebo. Across all participants regardless of trial completion, Lilly said average weight loss was 25 pounds, or 11.1%, versus 5.3 pounds, or 2.1%, on placebo. (prnewswire.com) Lilly is also pushing ahead with retatrutide, an experimental weekly injection that targets three hormone pathways instead of one. Top-line Phase 3 results released in March showed reductions in hemoglobin A1C and body weight in adults with type 2 diabetes, but retatrutide is still investigational and not approved. (pharmacytimes.com) (clinicaltrials.gov) (drugs.com) For now, the immediate change is simpler: Lilly has moved the obesity drug race onto pharmacy shelves in tablet form, with a United States launch that began on April 9. (prnewswire.com)