Lilly Expands Early Access to Retatrutide
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- Eli Lilly confirmed it will allow other patients to apply for early access to retatrutide, an unapproved obesity drug, after granting special access to an "apparently well-connected" 79-year-old patient.
- The initial patient accessed retatrutide in April via the U.S. Food and Drug Administration's "compassionate use" program, which governs pre-approval access to experimental medicines.
- Lilly's public posture shift came six weeks after STAT first reported on the expanded access program and followed follow-up inquiries from a handful of doctors who had not received replies from the drugmaker.
- Separately, the California Supreme Court ruled 6-to-1 in favor of Gilead Sciences, overturning a state appeals court decision that had raised industry alarm that drugmakers could be held liable for innovation choices.
- The Gilead case was brought by thousands of patients alleging the company was negligent for slow-walking development of a safer HIV medicine while continuing to sell an older, less safe drug.
- The pharmaceutical industry had argued that the lower-court ruling could dissuade innovation by exposing drugmakers to legal liability over development decisions.
Why it matters: Lilly's shift toward more transparent early access to retatrutide came only after media scrutiny exposed the company's selective program. The 6-to-1 California ruling shields drugmakers from liability over innovation decisions — a stance the industry said was needed to avoid chilling drug development.
