PLYMOUTH MEETING, PA — Harmony Biosciences (Nasdaq: HRMY) said the U.S. Food and Drug Administration has approved a supplemental new drug application for WAKIX (pitolisant) tablets to treat cataplexy in pediatric patients 6 years and older with narcolepsy.
The approval expands WAKIX’s label to include cataplexy in children, making it indicated for excessive daytime sleepiness or cataplexy in patients 6 years and older with narcolepsy, according to the company.
WAKIX was previously approved in August 2019 for excessive daytime sleepiness in adults with narcolepsy and in October 2020 for cataplexy in adults. In June 2024, the FDA approved the drug for excessive daytime sleepiness in pediatric patients 6 years and older.
Kumar Budur, chief medical and scientific officer at Harmony, said the expanded approval provides clinicians with an additional treatment option for pediatric patients.
“With this approval, clinicians now have the option to prescribe WAKIX to treat excessive daytime sleepiness, cataplexy, or both, in patients 6 years and older with narcolepsy,” Budur said.
Jeffrey M. Dayno, president and chief executive officer of Harmony Biosciences, said the company is seeking pediatric exclusivity for the drug, which, if granted, would extend regulatory exclusivity by six months.
WAKIX is a selective histamine 3 receptor antagonist/inverse agonist. The company said its efficacy may be mediated through activity at H3 receptors that increase the synthesis and release of histamine, a wake-promoting neurotransmitter.
The drug was granted orphan drug designation for narcolepsy in 2010 and breakthrough therapy designation for cataplexy in 2018. WAKIX was designed and developed by Bioprojet of France, and Harmony holds an exclusive U.S. license to develop, manufacture and commercialize pitolisant.
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