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Will Zevra Therapeutics receive the $150M Priority Review Voucher by end of 2024?
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Zevra's Miplyffa Receives FDA Approval, Eligible for $150M Voucher
Sep 20, 2024, 03:00 PM
Zevra Therapeutics, formerly KemPharm, has received FDA approval for its drug Miplyffa (arimoclomol) to treat Niemann-Pick disease type C (NPC), a rare and fatal genetic disorder. This approval makes Miplyffa the first treatment to be approved for NPC. The approval also makes Zevra eligible to receive a Priority Review Voucher worth approximately $150 million. Miplyffa is approved for use in combination with miglustat for patients aged 2 and older. The PDUFA date for the drug was September 21, 2024.
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