Eli Lilly NYSE:LLY will give a limited number of patients access to retatrutide, its experimental obesity drug, before U.S. approval, the company said. A spokesperson said it is "medically appropriate to make authentic retatrutide available before FDA approval," consistent with agency guidance, and that Lilly is reviewing requests from healthcare providers. Shares were unchanged.
Patients must be 18 or older, have refractory obesity despite tolerating the highest approved dose of existing obesity therapy, and have at least two serious or life-threatening obesity-related complications for which they are receiving care. They must also be unable to enroll in an ongoing trial of retatrutide or a comparable investigational treatment.
Retatrutide targets three metabolic hormones, GLP-1, GIP and glucagon. Zepbound, Lilly's current injectable obesity drug, targets two. In July the company reported that an 80-week trial in adults with severe obesity and established heart disease produced average weight loss of 22.6% at the highest weekly dose. Lilly plans to file for approval in the first quarter of next year.