The U.S. Food and Drug Administration (FDA) requested additional data from Eli Lilly regarding potential liver injury risks for its new obesity treatment. This request initiates a more intensive safety review for the drug, which originally received priority review approval.
The FDA mandated post-marketing studies to evaluate cardiovascular risks and the drug's impact on gastric emptying. Additional studies will examine the treatment's effects during lactation.
Eli Lilly stated that late-stage clinical trials showed no evidence of drug-related liver damage. The company expressed confidence in the comprehensive safety data provided by its clinical program.