Zevra Therapeutics (NASDAQ: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (“NDA”) for arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (“NPC”) to the U.S. Food and Drug Administration (“FDA”) on Dec. 22, 2023. Based on standard NDA resubmission review timelines, the company anticipates an acknowledgment letter from the FDA that the resubmission is complete and setting the PDUFA date within 30 days. Zevra expects the NDA to be classified as Class II, which would be subject to a review period by the FDA within six months from the date of submission. “The Zevra team has worked diligently to deliver a high quality and thorough resubmission of the NDA for arimoclomol following multiple interactions with the FDA and after incorporating direction from the agency,” said Neil McFarlane, president and chief executive officer of Zevra. “We continue to accelerate our launch preparations in anticipation of FDA approval and believe we are one step closer to getting arimoclomol into the hands of patients who are seeking a treatment.”
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About Zevra Therapeutics
Zevra Therapeutics is a rare disease company melding science, data and patient needs to create transformational therapies for diseases with limited or no treatment options. With unique, data-driven clinical, regulatory and commercialization strategies, the company is overcoming complex drug development challenges to bring much-needed therapies to patients. With both regulatory and clinical-stage product candidates, the company is building its commercial capability to make new therapies available to the rare disease community.
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