Pharma Focus Asia

RareStone Group Received Approval for Pitolisant (Wakix) by China's NMPA

Wednesday, July 05, 2023

RareStone Group recently announced that the Chinese National Medical Products Administration (NMPA) has approved pitolisant, also known as Wakix, for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. 

This approval makes pitolisant the first approved innovative drug for narcolepsy in China and the only drug for narcolepsy.

Pitolisant, or Wakix, is a medication that acts as a selective histamine 3 (H3) receptor antagonist/inverse agonist. It received orphan drug designation for the treatment of narcolepsy from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Additionally, the FDA has recognised it as a breakthrough therapy.

Narcolepsy is a rare neurological disorder characterised by sleep-wake state instability. The condition is primarily characterised by symptoms such as excessive daytime sleepiness (EDS), cataplexy (sudden loss of muscle tone triggered by emotions), and nocturnal sleep disturbances. Pitolisant offers a new treatment option for patients with narcolepsy in China.

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024ISPE Singapore Affiliate Conference & Exhibition 2024Rehab Expo 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024