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FDA Approves Pitolisant for Narcolepsy

We at Chion Foundation would like to congratulate Harmony Biosciences on FDA’s approval of pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy (with or without cataplexy). We are pleased to share with you below a message that Harmony would like to communicate with the Prader-Willi Syndrome (PWS) community. We look forward to working with them in this very important effort.


As you may have heard, on August 14, Harmony Biosciences, LLC (Harmony) announced that the U.S. Food and Drug Administration approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. Based on questions we have been receiving from the Prader-Willi Syndrome (PWS) community, we would like to provide you with an update related to our clinical development program for PWS.

Harmony is very interested in evaluating pitolisant in people living with PWS. Our company is currently pursuing a clinical development program, for which we have engaged with the FDA, with the intent of characterizing the safety, efficacy and appropriate dosing of pitolisant in treating some of the symptoms experienced by patients with PWS.

At Harmony, it is inherent in our culture to keep patients at the heart of everything we do, including addressing unmet medical needs and developing treatments that may help people living with rare diseases. We understand there is a great need and sense of urgency for new treatments in the PWS community. Harmony is committed to engaging with the PWS community as we explore the potential for pitolisant in patients with PWS.




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