Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy.
“We are excited to achieve this important milestone for pediatric narcolepsy patients who experience cataplexy,” said Kumar Budur, M.D., M.S., Chief Medical and Scientific Officer of Harmony Biosciences. “With this approval, clinicians now have the option to prescribe WAKIX to treat excessive daytime sleepiness, cataplexy, or both, in patients 6 years and older with narcolepsy.”
WAKIX was approved by the FDA in August 2019 for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy, with approval expanded to include cataplexy in adult patients in October 2020. The FDA approved WAKIX for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy in June 2024.
“WAKIX is now the first-and-only FDA-approved treatment option for both pediatric and adult narcolepsy patients with or without cataplexy that is not scheduled as a controlled substance, an important distinction that supports its clinical utility,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “We continue to advance our efforts toward obtaining pediatric exclusivity for WAKIX, which, if granted, would add an additional six months of regulatory exclusivity for this growing franchise. Our sights are now set on further growing, extending and expanding the value of pitolisant through additional indications with our next-generation formulations, which have utility patents filed out to 2044.”
Source: Harmony Biosciences
