Eli Lilly asked for additional safety data on obesity pill, Reuters reports

The FDA has requested additional data from Eli Lilly (LLY) on potential liver injury linked to its newly approved obesity pill, along with post-marketing studies on cardiovascular risks and gastric emptying, Reuters’ Sriparna Roy reports. The agency also mandated a lactation study, as the drug, approved under a priority review program, continues to undergo closer safety monitoring. A Lilly spokesperson said to Reuters that there have been no indications of liver damage associated with the drug in late-stage testing, adding that “The FDA approved Foundayo based on its review of data from the ATTAIN clinical program, with post-approval requirements consistent with the agency’s standard approach to ongoing safety evaluation of newly approved medicines.”