Applied Therapeutics Provides Govorestat NDA Regulatory Update
DENVER, Colo., Sep 18, 2024 (247marketnews.com)- Applied Therapeutics (Nasdaq: APLT) provided an update on the ongoing U.S. Food and Drug Administration (FDA) New Drug Application (NDA) review of govorestat for the treatment of Classic Galactosemia, following the Company’s recently completed late-cycle review meeting, in which the FDA stated that the previously scheduled Advisory Committee meeting was no longer required.
The FDA informed Applied Therapeutics that it still expects the Priority Review of the NDA to take place in October 2024, while the previously announced Prescription Drug User Fee Act (PDUFA) target action date remains on track for November 28, 2024.
Shoshana Shendelman, PhD, CEO and Founder of Applied Therapeutics, “We are incredibly pleased by the ongoing collaborative dialogue with the FDA during the NDA review process, and we look forward to continuing to work together with the agency to bring the first potential treatment to Classic Galactosemia patients.
“Galactosemia is a progressive disease in urgent need of treatment, and the potential approval of govorestat will be transformative for the many patients and families living with this serious disease. Our commitment to the Classic Galactosemia community is further supported by our thoughtful commercial preparation, focused on establishing an effective patient access program, high physician awareness and strong payor engagement.”
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