Lilly Opens Retatrutide Access; California Court Backs Gilead
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- Eli Lilly confirmed it will allow other patients to apply for early access to retatrutide, its unapproved obesity drug, after initially providing it to a 79-year-old patient in April through the FDA's compassionate use program.
- The policy shift came six weeks after STAT first reported the expanded access and followed inquiries from several doctors who had not yet received a reply from the drugmaker.
- Lilly's reversal marks a striking change from its previously opaque public posture on the special access program, which had offered little information about who could obtain the drug.
- California Supreme Court ruled 6-1 in favor of Gilead Sciences, overturning a two-year-old state appeals court decision that the company could be held liable for slow-walking development of an HIV medicine safer than one it was already selling.
- The appellate ruling had alarmed the pharmaceutical industry with fears that drug development decisions could be shaped by legal liability concerns and dissuade innovation.
Why it matters: Lilly's reversal shifts the company from opacity to openness on compassionate use for retatrutide, potentially expanding access for patients with obesity. The California ruling protects Gilead and other drugmakers from liability tied to R&D prioritization, directly addressing industry alarm that innovation could be chilled by lawsuits over which drugs a company chooses to develop.
