Novel narcolepsy med to challenge blockbuster Xyrem in USA

15 August 2019

USA-based Harmony Biosciences, a part of the Paragon Biosciences corporate family, has won US approval for Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy.

The first-in-class medication, a selective histamine 3 receptor antagonist, was granted orphan drug designation for the treatment of narcolepsy in 2010.

France-based Bioprojet has marketed the product in Europe since its approval by the European Medicines Agency in 2016. Harmony acquired exclusive US rights to the drug from Bioprojet in 2017.

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