Lilly opens retatrutide expanded access to patients before FDA approval
Eligible patients must be unable to enroll in a trial, be 18 or older, have refractory obesity on the highest approved dose, and have two obesity-related complications.
MH
By Maren Holt · Senior Reporter, GLP-1
Aug 4 03:00 ETSource: Reuters
The wire
- 01Eli Lilly said it will supply its triple GIP/GLP-1/glucagon agonist retatrutide to a limited number of patients outside clinical trials, with requests reviewed from health care providers.
- 02Retatrutide remains in Phase 3 for obesity, type 2 diabetes and obstructive sleep apnea; Lilly says patients should not take anything claiming to be retatrutide outside its trials, a warning aimed at gray-market copies.
- 03The company calls the program consistent with FDA expanded access guidance; no approval, pricing or volume figures have been disclosed, and eligibility is narrow.
From the source
Read at reuters.comEli Lilly to offer early access to next-gen obesity drug to some patients