By Sneha S K and Deena Beasley
Aug 3 (Reuters) – Eli Lilly said on Monday it would allow a limited number of patients to have early access to its experimental obesity drug, retatrutide, before its U.S. 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 authentic retatrutide available before FDA approval, consistent with FDA’s guidance,” a company spokesperson said.
The spokesperson added that Lilly has built an expanded access program “that does that and are actively reviewing requests from health care providers.”
Eligible patients must be aged 18 or older, have refractory obesity despite tolerating the highest approved dose of obesity therapy, and have at least two serious or life-threatening obesity-related complications for which they are receiving care.
Patients should also be unable to participate in an ongoing clinical trial of retatrutide or a comparable investigational treatment.
STAT News was the first to report on the expanded access program. It had previously also reported that the company granted a single 79-year-old patient special access to retatrutide.
Retatrutide is designed to target three different metabolic hormones: GLP-1, GIP and glucagon. The company’s current injectable obesity drug, Zepbound, targets GLP-1 and GIP.
Lilly said in July that an 80-week trial of adults with severe obesity and established heart disease showed average weight loss of 22.6% for the highest weekly dose of retatrutide.
The company plans to file for approval for retatrutide with the FDA in the first quarter of next year.
(Reporting by Sneha S K in Bengaluru and Deena Beasley in Los Angeles; Editing by Shreya Biswas)
