Eli Lilly Expands Access to Unapproved Retatrutide
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- Eli Lilly confirmed Monday it will allow additional patients to apply for special access to retatrutide, an unapproved obesity drug, roughly six weeks after STAT reported the company had granted access to a single 79-year-old patient.
- The announcement followed STAT's inquiry to Lilly about expanded access requests from a handful of doctors who had not yet received a reply from the drugmaker.
- A Lilly spokesperson said the drug will be made available 'for a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial,' calling the move medically appropriate and consistent with FDA guidance.
- Lilly is now actively reviewing requests from health care providers for early access to retatrutide, according to the company's statement.
- The decision marks a notable shift in the pharmaceutical giant's public stance — it had previously offered little information about its special access program.
Why it matters: The policy shift gives a clearer pathway to retatrutide for seriously ill patients who cannot enroll in clinical trials, and signals that Lilly is willing to engage more openly about its compassionate use program after weeks of silence toward requesting physicians.
