Posted by Michael Wonder on 18 Feb 2026
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) for the treatment of cataplexy in paediatric narcolepsy
17 February 2026 - Harmony Biosciences today announced that the US FDA has approved its supplemental new drug application for Wakix (pitolisant) tablets for the treatment of cataplexy in paediatric patients 6 years of age and older with narcolepsy.
Wakix is now the first and only FDA approved non-scheduled treatment for paediatric and adult narcolepsy patients with or without cataplexy.
