FDA & Government News

FDA Broadens Pitolisant Label

The US Food and Drug Administration approves pitolisant (WAKIX) tablets for the treatment of cataplexy in pediatric patients aged 6 years and older with narcolepsy.

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Pitolisant is now the first non-scheduled treatment approved in the US for narcolepsy, applicable to both pediatric and adult patients. This enables clinicians to prescribe WAKIX for treating excessive daytime sleepiness and cataplexy in patients 6 years and older, as noted by Dr. Kumar Budur from Harmony Biosciences. Previously approved in 2019 for adults, the drug's indication was expanded in June 2024 to include pediatric patients. Pitolisant, a selective histamine receptor antagonist, addresses narcolepsy's core symptoms linked to hypocretin loss.

Original Source(s)

FDA Broadens Pitolisant Label

The US Food and Drug Administration approves pitolisant (WAKIX) tablets for the treatment of cataplexy in pediatric patients aged 6 years and older with narcolepsy.

  • by Kathryn Wighton

  • February 17, 2026

  • 2 min

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