FDA approves Wakix for children as young as six with narcolepsy and cataplexy

The U.S. Food and Drug Administration (FDA) has expanded the approved use of Wakix for younger patients. The drug, already prescribed for adults with narcolepsy, can now be given to children aged six and older. This decision follows clinical trials showing its safety and effectiveness in pediatric cases.

Wakix, known chemically as Pitolisant, was first authorised in 2019. At that time, it treated excessive daytime sleepiness in adults with narcolepsy. A year later, its label was updated to include adults suffering from cataplexy—a sudden loss of muscle tone linked to the condition.

The latest approval extends its use to children. The FDA based its decision on results from the HARMONY III study, which involved patients aged six to seventeen. Data confirmed the drug's ability to manage narcolepsy with cataplexy in this age group.

Harmony Biosciences, the drug's manufacturer, announced the expanded label. The company highlighted that Wakix is now the first non-scheduled treatment for pediatric narcolepsy with cataplexy in the U.S.

With this approval, Wakix becomes an option for children as young as six. Doctors can now prescribe it for both excessive daytime sleepiness and cataplexy in pediatric narcolepsy. The decision marks a step forward in treatment availability for younger patients.