Eli Lilly Releases Updated Foundayo Safety Data Following FDA Request, Cites 11,000-Patient Program with No DILI Signal
Eli Lilly's Global Patient Safety team responded to the FDA's request for updated Foundayo safety information on May 4, concluding the FAERS event was 'not reasonably related to Foundayo.' The company pointed to the 11,000-participant ACHIEVE and ATTAIN program — followed for up to two years — where the liver safety profile of Foundayo was similar to placebo and active comparator medicines, with no cases of drug-induced liver injury observed and no hepatic safety signal detected. ACHIEVE-4 specifically included a thorough drug-induced liver injury (DILI) analysis with no hepatic signals, consistent with the 57% lower all-cause death rate (HR 0.43) seen versus insulin glargine in that arm.