To be eligible for the FDA’s new Commissioner’s National Priority Voucher program, a drug must meet certain national health interests. Qualifying medicines could be reviewed in one to two months, down from the standard 10 months to a year.
Zevra Therapeutics received a priority review voucher for Miplyffa, the first FDA-approved treatment for the rare metabolic disorder Niemann Pick disease type C. Though Zevra has other drug candidates that could benefit from the voucher, the biotech is selling it to an undisclosed buyer.
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Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.