Eli Lilly to allow more patients to apply for special access to unapproved obesity drug

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

Six weeks after STAT reported that Eli Lilly granted a single 79-year-old patient special access to retatrutide, an unapproved obesity drug, the company confirmed on Monday that it will allow other patients to apply for early access. 

The announcement comes after STAT asked Lilly about the requests for expanded access from a handful of doctors who had not yet received a reply from the drugmaker. It marks a striking change in the public posture of the pharmaceutical giant, which had previously offered little information about the special access program. 

“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 Lilly spokesperson told STAT. The company said it is actively reviewing requests from health care providers.