#Drug-Induced-Liver-Injury

2 stories

Regulatory May 4, 2026 · View digest

Foundayo Liver Failure FAERS Report Surfaces; Lilly Stock Falls 3% Premarket Before Recovering

An FDA Adverse Event Reporting System (FAERS) entry logged April 30 surfaced publicly May 4, documenting hepatic failure in a 56-year-old male patient on Foundayo (orforglipron). The case was marked for expedited review and could have occurred at or before April 15 — Foundayo only launched April 9. There have been 34 total Foundayo FAERS reports so far, with two considered serious. LLY traded down nearly 3% premarket — hitting roughly $936 — before recovering on Lilly's response. Foundayo's label carries a warning that the medication is 'not recommended for use in patients with severe hepatic impairment' (orforglipron is primarily hepatically metabolized), but mild and moderate liver impairment is allowed at standard dose.

Industry May 4, 2026 · View digest

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.