The National Medical Products Administration (NMPA) has approved pitolisant as a treatment for excessive daytime drowsiness (EDS) or cataplexy in adults with narcolepsy. This marks a significant advancement in the therapeutic options available for narcolepsy patients in China.
Pitolisant’s Mechanism of Action and International Designations
Pitolisant is a selective histamine 3 (H3) receptor antagonist/inverse agonist that has received breakthrough therapy designation and orphan drug designation (ODD) in the United States, along with another ODD in the European Union (EU). The drug was approved in the EU and the US in March 2016 and August 2019, respectively, for the treatment of episodic sleeping sickness with or without sudden onset cataplexy.
Pitolisant’s First Prescription and Licensing Deal in China
Pitolisant was first prescribed in Boao of Hainan province in May 2021. RareStone, a Chinese pharmaceutical company, struck a licensing deal with France-based Bioprojet Pharma in 2020, securing development rights in China for the drug. This week, the drug was prioritized for review as a treatment for EDS or cataplexy in adolescents and children over 6 years old with narcolepsy in the country.-Fineline Info & Tech
