Lilly debuts more Foundayo data as FDA requests post‑marketing trials

Lilly released Phase III ACHIEVE‑4 results showing Foundayo met cardiovascular non‑inferiority and showed no liver safety signal in that trial, and the FDA has asked for post‑marketing studies focused on broader populations including children aged 6–12, pregnant individuals, and long‑term thyroid monitoring.

Eli Lilly has released additional clinical data for Foundayo (orforglipron) after the US Food and Drug Administration raised questions about the therapy's safety. The FDA's NDA approval letter asked Lilly to carry out clinical studies examining Foundayo across the general population and specifically in patients aged six to 12 and in pregnant individuals. The agency cited early safety signals that it said could not be resolved through nonclinical or observational studies, including possible risks of major adverse cardiovascular events, drug‑induced liver injury and a type of thyroid cancer. Lilly also published Phase III ACHIEVE‑4 results and is preparing a separate NDA submission for type 2 diabetes by the end of Q2 2026. Key details: - The FDA requested post‑marketing clinical studies to evaluate Foundayo's safety in broader populations, including paediatric patients aged 6–12, pregnant individuals, and long‑term monitoring for medullary thyroid carcinoma over 15 years. - Lilly released ACHIEVE‑4 (Phase III) results reporting cardiovascular non‑inferiority versus insulin glargine and no liver toxicity signal in that study. - The company plans to submit a new drug application for Foundayo in type 2 diabetes to the FDA by the end of Q2 2026, as reported in the article. - Foundayo's initial approval was granted through the Commissioner's National Priority Voucher (CNPV) scheme, a detail noted in the article. - A GlobalData analyst said the ACHIEVE‑4 findings reduce safety concerns and that post‑approval liver monitoring requirements were expected for an expedited review, according to the article. Summary: The ACHIEVE‑4 data addresses some FDA safety questions by showing cardiovascular non‑inferiority and no liver signal within that trial, while the FDA has asked for further post‑marketing studies in children, pregnant individuals and long‑term thyroid monitoring. Lilly's planned diabetes NDA and the scope of the post‑marketing commitments were reported as the next regulatory steps.