Harmony Biosciences Holdings, Inc. 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. The FDA accepted the sNDA and granted priority review based on a Phase 3 multicenter, randomized, placebo-controlled study conducted by Bioprojet that evaluated the safety and efficacy of pitolisant in pediatric patients 6 to < 18 years with narcolepsy with or without cataplexy.

Based on the results of this study, Bioprojet received approval from the European Medicines Agency last year extending the indication for pitolisant to include the treatment of narcolepsy in children aged 6 years and older, with or without cataplexy.