FDA asks Lilly for liver data

The Food and Drug Administration has told Eli Lilly to run post-marketing liver studies on its newly approved obesity pill, Foundayo, after reports of possible liver injury surfaced this month. (fda.gov) (reuters.com) Foundayo, the brand name for orforglipron, won United States approval on April 1, 2026 for adults with obesity, or overweight adults with at least one weight-related medical condition. The approval letter says the application was filed on January 20 and cleared effective April 1. (fda.gov 1) (fda.gov 2) The drug is a glucagon-like peptide-1 receptor agonist, a class that mimics a gut hormone to reduce appetite. Unlike Lilly’s Zepbound, which is an injection, Foundayo is a once-daily pill that can be taken with or without food. (fda.gov) (lilly.com) That matters because Lilly launched Foundayo as the first approved oral glucagon-like peptide-1 option for weight loss in the United States, with shipments beginning in early April through LillyDirect and retail pharmacies. Lilly said the list launch terms started at $25 a month for some commercially insured patients and $149 a month for self-pay. (lilly.com 1) (lilly.com 2) The Food and Drug Administration’s request does not mean the agency pulled the drug from the market. Post-marketing studies are follow-up research regulators can require after approval to track safety questions that may be too rare or too new to settle before launch. (fda.gov) (reuters.com) Foundayo’s label already carries a boxed warning about thyroid C-cell tumors seen with drugs in this class in rodents, and it warns about pancreatitis and severe gastrointestinal reactions. The highlights page shown in the current label excerpt does not list liver injury among the main warnings. (fda.gov) (pi.lilly.com) Lilly said in its April 1 release that patients on the highest dose who stayed on treatment in the ATTAIN-1 trial lost an average 27.3 pounds, or 12.4% of body weight, versus 2.2 pounds on placebo. The company also said the pill lowered waist circumference, triglycerides, non-high-density lipoprotein cholesterol, and systolic blood pressure across doses in the program. (lilly.com) The approval also drew attention because the Food and Drug Administration reviewed the drug unusually fast. The agency said it cleared Foundayo 50 days after filing, 294 days before the original January 20, 2027 target date, under its Commissioner’s National Priority Voucher pilot program. (fda.gov) What happens next is narrower than the launch itself: Lilly keeps selling the pill while it gathers the liver data the regulator asked for. The new question is whether those follow-up studies confirm a signal or rule it out. (reuters.com)