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FDA Approves Wakix for Cataplexy in Pediatric Narcolepsy Patients

Feb 25, 2026

The FDA approved pitolisant (Wakix) for treating cataplexy in children ages 6 and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.

FDA Approves WAKIX for Cataplexy Treatment in Pediatric Narcolepsy Patients

Feb 17, 2026

The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.