Eli Lilly’s newly approved oral obesity drug, Foundayo, has drawn attention from the Food and Drug Administration after the agency detected serious safety risks related to heart and liver health. The FDA communicated these concerns in an April 1 letter, requesting that Lilly conduct a postmarketing clinical trial to further assess these risks.
The FDA identified issues including retained gastric contents, unexpected cases of major adverse cardiovascular events, and drug-induced liver injury. In its approval letter for Foundayo, the agency said, “We have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess” these risks.
Lilly is currently conducting the Phase 3 ACHIEVE-4 trial with daily Foundayo in patients who are obese or overweight with type 2 diabetes and increased cardiovascular risk. The FDA has asked that this study also evaluate drug-induced liver injury. ACHIEVE-4 was expected to finish last month, with a final report due by July. In addition to heart and liver assessments, the FDA requested several other postmarketing studies focusing on outcomes such as pregnancy effects, child development impacts, and potential thyroid cancer risks.
Analysts at BMO Capital Markets told investors that while it is notable for the FDA to require multiple postmarketing trials for Foundayo, they believe “we do not expect these studies to have any meaningful impact on the competitive positioning” of the drug. They added: “We view this as a reflection of conservatism from FDA,” suggesting that successful completion of these studies could strengthen confidence in oral incretin therapies like Foundayo.
Foundayo received approval on April 1 amid growing competition between Eli Lilly and Novo Nordisk in oral obesity treatments. Novo Nordisk's Wegovy pill was approved late last year; however, analysts suggest Foundayo may become a strong competitor due in part to its small-molecule design which allows faster production compared to peptide-based drugs like Wegovy.
Looking ahead, investors are watching for updates during Lilly’s first-quarter earnings call scheduled for April 30 regarding how well Foundayo is performing since its launch.
