HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR WAKIX® (PITOLISANT) IN PEDIATRIC PATIENTS WITH NARCOLEPSY

"Following the FDA's decision to grant priority review, we are very pleased with the Agency's timely review and approval of WAKIX for pediatric narcolepsy patients with excessive daytime sleepiness," said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. "EDS is the primary symptom experienced by all patients with narcolepsy and this approval for WAKIX, as the first-and-only FDA-approved non-scheduled treatment option for narcolepsy, makes this important treatment option ...