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Nine PDUFA dates on FDA’s agenda in September
Decision on Zevra’s arimoclomol follows positive AdCom vote
August 30, 2024 7:43 PM UTC
FDA has at least nine PDUFA dates on its agenda for September, including an Hsp70 inducer for a rare genetic disease that was given a thumbs up by an advisory committee in August.
The Genetic Metabolic Diseases Advisory Committee voted 11-5 that arimoclomol from Zevra Therapeutics Inc. (NASDAQ:ZVRA) is effective in Niemann-Pick disease type C disease. Arimoclomol, an orally delivered Hsp70 inducer, led to a reduction in long-term disease progression in an open-label Phase II/III trial. ...
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