Harmony Biosciences gets FDA nod for Wakix

BY Sandra Levy

Harmony Biosciences has received the Food and Drug Administration’s blessing for Wakix (pitolisant) for the treatment of excessive daytime sleepiness in adults with narcolepsy. The product is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the Drug Enforcement Administration, the company said.

“We are extremely proud to bring Wakix to market for those living with narcolepsy, a chronic, debilitating, rare neurologic disorder,” said Harmony’s chairman and CEO John Jacobs. “At Harmony, we share a vision to develop novel treatment options for people living with rare diseases, with a focus on those that affect the central nervous system. The approval of WAKIX strengthens our commitment to making that vision a reality.”

“The approval of Wakix provides healthcare professionals managing people living with narcolepsy a new and important treatment option for their patients,” said Harmony’s chief medical officer, Jeffrey Dayno. “Additionally, Wakix is the only non-scheduled treatment option approved for adult patients with narcolepsy, and it offers an important benefit/risk profile to address the unmet medical need that exists in people living with narcolepsy.”

Wakix will be commercially available in the fourth quarter of 2019.


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