Harmony Biosciences obtains FDA OK for new indication for Wakix

The Food and Drug Administration has approved Harmony Biosciences’ Wakix (pitolisant) for to treat excessive sleepiness associated with narcolepsy in adults.  

Wakix is the first and only treatment approved by the FDA for people with excessive daytime sleepiness — cataplexy — associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration.

Wakix received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.           

"All people living with narcolepsy have excessive daytime sleepiness and up to two-thirds of them also experience cataplexy, which is one of the most debilitating symptoms of this chronic, rare neurological disorder," said Harmony's chief medical officer, Jeffrey Dayno.

"This approval underscores our ongoing commitment to support people who are living with narcolepsy," said John Jacobs, Harmony's president and CEO. "At Harmony, we always keep patients at the heart of all we do and with this approval, we are inspired to continue our mission to develop novel treatment options for those living with rare, neurological disorders who have unmet medical needs."