24/7 Market News- FDA’s GeMDAC Votes in Favor of Zevra’s Arimoclomol as Effective Treatment for Patients with Niemann-Pick Disease Type C
DENVER, Colo., Aug 05, 2024 (247marketnews.com)- Zevra Therapeutics, Inc. (Nasdaq: ZVRA) stated that the U.S. Food and Drug Administration’s (FDA) Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted favorably (11 yes, 5 no) that the data support that Arimoclomol is effective in the treatment of patients with Niemann-Pick disease type C (NPC).
Zevra’s President and CEO, Neil F. McFarlane, commented, “We are extremely pleased with the committee’s recognition of the benefits of arimoclomol for people living with NPC.
“Based on the totality of the clinical data, including data from the pivotal trial, the long-term data from the arimoclomol open label extension study, and data from our expanded access programs (EAP: NCT04316637), we remain confident in the clinical benefit offered by arimoclomol as a treatment for NPC, and are optimistic about its continued path to approval.”
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