The U.S. Food and Drug Administration (FDA) has asked Eli Lilly to provide additional data on potential liver injury risks associated with its newly approved obesity drug, Foundayo, according to sources familiar with the matter. The request comes just weeks after the agency greenlit the medication, signaling heightened scrutiny over safety concerns.
Foundayo, a once-daily oral pill, was approved in March 2026 as a treatment for chronic weight management in adults with obesity or overweight conditions. The drug’s approval was based on clinical trials showing significant weight loss benefits. However, post-market reports have raised questions about rare but serious liver-related adverse events, prompting the FDA to seek further investigation.
‘The FDA’s request for additional data is not uncommon for newly approved drugs, especially those targeting a widespread condition like obesity,’ said one pharmaceutical analyst, who spoke on condition of anonymity. ‘Safety monitoring post-approval is a standard part of the regulatory process.’
Eli Lilly has not publicly commented on the FDA’s request. However, company officials reportedly emphasized their commitment to patient safety in internal communications. Foundayo is part of a competitive market for obesity treatments, which includes Novo Nordisk’s Wegovy and Ozempic.
The FDA’s move highlights the challenges of balancing rapid approval of innovative therapies with rigorous safety oversight. If further studies confirm liver injury risks, the agency could issue warnings, restrict prescribing, or even withdraw the drug from the market. Analysts suggest that such actions could impact Eli Lilly’s revenue projections, as Foundayo was expected to generate billions in annual sales.