Eli Lilly’s ACHIEVE-4 Shows Non-Inferior MACE Rates as FDA Seeks Paediatric, Pregnancy Trials
Eli Lilly released Phase III ACHIEVE-4 data showing Foundayo’s cardiovascular event rate is non-inferior to insulin glargine and detected no liver toxicity signal. The FDA has asked Lilly to conduct post-marketing safety trials in paediatric and pregnant populations and assess medullary thyroid cancer risk over 15 years.
1. FDA Requests Additional Safety Trials
The FDA requested clinical studies evaluating Foundayo’s safety across general populations, with specific focus on patients aged 6-12 and pregnant individuals, citing concerns over potential cardiovascular events, liver injury and thyroid cancer signals.
2. Phase III ACHIEVE-4 Cardiovascular Results
The Phase III ACHIEVE-4 trial demonstrated Foundayo’s major adverse cardiovascular event rate non-inferior to insulin glargine and revealed no liver toxicity signal, addressing initial safety concerns raised by regulators.
3. Upcoming Type 2 Diabetes NDA Submission
Based on ACHIEVE-4 findings, Lilly plans to submit a new drug application for Foundayo in type 2 diabetes by the end of Q2 2026, aiming to broaden its therapeutic indications.
4. Long-Term Safety Data Requirements
Lilly must collect 15-year data on medullary thyroid carcinoma incidence and study outcomes in mothers, foetuses and breastfed infants to satisfy post-marketing surveillance requirements.