Harmony Says FDA Approves Wakix for Cataplexy in Children With Narcolepsy

MT Newswires Live02-17

Harmony Biosciences (HRMY) said Tuesday it has received the US Food and Drug Administration approval for its supplemental new drug application for Wakix tablets to treat cataplexy in children at least 6 years old with narcolepsy.

Wakix is now approved to treat excessive daytime sleepiness, cataplexy, or both, in patients 6 years and older with narcolepsy, the company said.

The regulator approved Wakix in 2019 to treat excessive daytime sleepiness in adults with narcolepsy, with approval expanded in 2020 to include cataplexy in adults. The FDA also approved Wakix in 2024 to treat excessive daytime sleepiness in children at least 6 years old with narcolepsy, the company added.

Shares of Harmony Biosciences were up 1% in recent Tuesday premarket activity.

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