Harmony Biosciences Receives FDA Priority Review For Wakix

(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) announced on Wednesday that the FDA has given priority review for its supplemental New Drug Application or sNDA for Wakix, also known as pitolisant tablets.

The drug candidate is intended for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients aged 6 years and above with narcolepsy.

The FDA has established a Prescription Drug User Fee Act target action date of June 21, 2024.

The company stated that the FDA granted priority review after reviewing a Phase 3 placebo-controlled study by Bioprojet. This study assessed the safety and effectiveness of pitolisant in pediatric patients aged 6 to under 18 years with narcolepsy, with or without cataplexy.