China's NMPA approves RareStone's Wakix for narcolepsy

5 July 2023

Chinese rare disease drug developer RareStone Group has received approval from the National Medical Products Administration (NMPA) for Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.

In China, pitolisant is the first approved innovative drug for narcolepsy and the only non-scheduled drug with narcolepsy indication. RareStone gained rights to the drug in China under a 2020 deal with France-based Bioprojet, which also licensed the drug to Harmony Biosciences (Nasdaq: HRMY) for the US market, where it was approved by the US Food and Drug Administration (FDA) in 2020.

Wakix is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA).

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