FDA asks Lilly for more data

The Food and Drug Administration has told Eli Lilly to run more studies on its new obesity pill, Foundayo, after spotting possible liver, heart and stomach-emptying risks in the drug’s review. (accessdata.fda.gov) Foundayo, the brand name for orforglipron, won United States approval on April 1 for adults with obesity, or overweight adults with at least one weight-related condition, and the drug is taken once a day by mouth. The Food and Drug Administration approved it 50 days after filing under the Commissioner’s National Priority Voucher pilot program. (fda.gov) A glucagon-like peptide-1 drug copies a gut hormone that helps people feel full and eat less. Foundayo is unusual because it is a pill, not an injection, and Lilly said it can be taken with or without food. (fda.gov) (investor.lilly.com) In the approval letter, the agency said Lilly must use a clinical trial, not an observational study, to assess signals of major adverse cardiovascular events, drug-induced liver injury and retained gastric contents. The letter also requires a lactation study measuring how much drug gets into breast milk. (accessdata.fda.gov) (fiercepharma.com) The Food and Drug Administration tied part of that work to ACHIEVE-4, a Phase 3 trial in patients with type 2 diabetes who are obese or overweight and already face elevated cardiovascular risk. BioSpace reported the agency wants the final safety report by July. (fiercepharma.com) (biospace.com) This does not reverse the approval. Post-marketing requirements let the agency keep a drug on the market while forcing the manufacturer to answer unresolved safety questions after launch. (fda.gov) (accessdata.fda.gov) The scrutiny lands as Lilly is trying to turn Foundayo into a global obesity franchise. BioSpace reported the company has filed orforglipron in more than 40 countries and is adding manufacturing capacity, including a $3 billion China investment over the next decade and about $125 million in Japan. (biospace.com) Lilly has pitched the pill as easier to use than injections and said patients on the highest dose who stayed on treatment lost an average of 27.3 pounds, or 12.4%, in the ATTAIN-1 trial. The Food and Drug Administration label also carries a boxed warning about thyroid C-cell tumor risk, a class warning common to glucagon-like peptide-1 drugs. (investor.lilly.com) (accessdata.fda.gov) Lilly did not lose the approval it won on April 1. But the company now has to prove, in new data from real post-approval studies, that the convenience of a daily obesity pill does not come with safety problems the agency still cannot fully size up. (accessdata.fda.gov)