FDA Clears Replimune Drug; Medicare Delays AbbVie Talks
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- FDA granted accelerated approval to Replimune's melanoma drug, to be marketed as Tudriqev, delivering a major win for the biotech after a tumultuous approval saga for the controversial treatment.
- The Replimune decision came after FDA advisers voted in support of the drug last week, despite agency staff concerns about the design and conduct of the key trial, with advisers citing a large enough efficacy signal and urgent patient need.
- Medicare modified selection criteria under the Inflation Reduction Act drug price negotiation process, delaying by seven years when a costly AbbVie medicine would become eligible for talks.
- A consumer advocacy group analysis concluded the CMS policy change likely hurts taxpayers while benefiting AbbVie and may help other drugmakers in future rounds.
- The CMS policy shift occurred as the agency prepared a new round of negotiations with drugmakers over prices the agency would pay for a limited number of drugs.
Why it matters: The FDA approved Replimune's melanoma drug despite staff concerns about trial design, overriding agency objections after advisers backed it. Separately, a Medicare policy change delayed AbbVie drug price negotiations by seven years, a shift advocacy groups say will hurt taxpayers while benefiting drugmakers.
