Feb 21 2024
U.S. Food and Drug Administration Grants Priority Review to Harmony Biosciences’ Application for WAKIX® (Pitolisant) in Pediatric Narcolepsy

PLYMOUTH MEETING, Pa., Feb. 21, 2024 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) granted priority review for its supplemental New Drug Application (sNDA) for WAKIX^® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients 6 years of age and older with narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 21, 2024.

Read full statement here.