The Chinese National Medical Products Administration (NMPA) has granted approval for RareStone Group’s pitolisant (Wakix) to treat excessive daytime sleepiness (EDS) or cataplexy in adult narcolepsy patients.

Pitolisant is a selective histamine 3 receptor antagonist/inverse agonist, classified as a first-line therapy option in the Chinese guidelines for the diagnosis and treatment of narcolepsy (2022). It is the first drug in the region to receive approval for narcolepsy and the sole non-scheduled drug for this indication.

The European Medicines Agency and the US Food and Drug Administration (FDA) have granted orphan drug designation for the therapy.

RareStone Group CEO Dr Shawn Xiang stated: “We are pleased to bring a new therapeutic option to Chinese narcolepsy patients to fill in the huge treatment gap.

“Aiming to bring more accessible and affordable treatment options to rare disease patients in China, we will continue working with the patient communities, government, industry and stakeholders from all sectors to promote developing and commercialising innovative treatments for rare diseases.”

In December 2021, the company entered a licensing agreement with Rhythm Pharmaceuticals to develop and market Imcivree (setmelanotide) in Greater China.

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The deal is intended to expedite access to Imcivree for obesity and hyperphagia.