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

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

By, Admin 7 July 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.

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