India, July 25 -- Zevra Therapeutics, Inc. (ZVRA) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the company's Marketing Authorization Application for Arimoclomol for the treatment of Niemann-Pick disease type C.
Niemann-Pick disease type C (NPC) is a rare, progressive, and life-threatening neurodegenerative disorder.
Under European regulatory procedures, Zevra plans to request a re-examination of the CHMP opinion and submit a detailed explanation outlining the basis for the request.CEO Neil F. McFarlane stated that while the outcome was disappointing, the company remains committed to exploring pathways to bring Arimoclomol to patients in Eu...