Eli Lilly Expands Early Access to Experimental Weight Loss Drug Retatrutide
On Monday, Eli Lilly revealed its intention to broaden the early access program for its unapproved weight loss medication, retatrutide, which had previously been available to just one individual. This move comes in response to feedback from doctors who reported a lack of communication from Lilly regarding patient access. According to a spokesperson for the company, the drug will now be accessible to a select group of patients who fulfill certain medical requirements and are unable to join clinical trials. Lilly aims to seek regulatory approval for retatrutide in the first quarter of 2027, a delay attributed to the necessity for additional manufacturing data. Positive outcomes have been observed in five late-stage trials, with participants experiencing an average weight loss of 28.3% over 80 weeks.
Key facts
- Eli Lilly confirmed Monday it will allow patients to apply for early access to retatrutide.
- The program previously granted access to a single patient.
- STAT reporting revealed multiple physicians had received no reply from Lilly.
- Lilly spokesperson said access is for patients who meet specific medical criteria and cannot enroll in clinical trials.
- Retatrutide engages three hormonal pathways: GLP-1, GIP, and glucagon.
- Lilly plans to file for regulatory approval in Q1 2027.
- Five late-stage trials produced positive results; highest dose led to 28.3% average weight loss over 80 weeks.
- Lilly intends to pursue regulatory filings for obesity, knee osteoarthritis pain, and obstructive sleep apnea.
Entities
Institutions
- Eli Lilly
- STAT
- FDA
- American Diabetes Association
- Novo Nordisk
Sources
- Quartz —