Eli Lilly Opens Limited Early Access Program for Obesity Drug Retatrutide Ahead of FDA Review

Aug 3 (Reuters) — Eli Lilly said on Monday it will allow a limited number of patients to receive early access to its experimental obesity medicine, retatrutide, before formal U.S. Food and Drug Administration (FDA) approval.

"For a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial, we believe it is medically appropriate to make retatrutide available before FDA approval, consistent with FDA's guidance," a company spokesperson said.

The company has established an expanded access program to provide this pathway and is actively reviewing requests submitted by health care providers. Eligible patients must be 18 or older, have refractory obesity despite tolerating the highest approved dose of an approved obesity therapy, and have at least two serious or life‑threatening obesity‑related complications for which they are receiving care.

To qualify, patients must also be unable to participate in an ongoing clinical trial of retatrutide or a comparable investigational treatment. STAT News was first to report the expanded access program and earlier reported that Lilly granted special access to a single 79‑year‑old patient.

How Retatrutide Works

Retatrutide is designed to act on three metabolic hormone pathways — GLP‑1, GIP, and glucagon — differentiating it from Lilly's current injectable obesity drug, Zepbound, which targets GLP‑1 and GIP only. In July, Lilly reported results from an 80‑week trial of adults with severe obesity and established heart disease in which the highest weekly dose of retatrutide produced an average weight loss of 22.6%.

Lilly plans to submit an application for U.S. FDA approval of retatrutide in the first quarter of next year and says the expanded access program is intended for patients with urgent medical need who cannot join a trial.

(Reporting by Sneha S K in Bengaluru and Deena Beasley in Los Angeles; Editing by Shreya Biswas)