The FDA will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) on August 2 to review the marketing application for Zevra Therapeutics Inc.’s (NASDAQ:ZVRA) arimoclomol for Niemann-Pick disease type C (NPC).
The application for arimoclomol has been assigned a Prescription Drug User Fee Act (PDUFA) action date of September 21, which was extended from June 21.
Previously known as KemPharm, Zevra Therapeutics acquired arimoclomol from Orphazyme for $12.8 million.
In 2021, the FDA issued a complete response letter to arimoclomol as a treatment option for Full story available on Benzinga.com