Bioprojet company Ozawade is approved in the EU, Langyu Group develops in China

The European Medicines Agency (EMA) recently approved the French Bioprojet company's drug Ozawade (pitolisant, tilolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) in adult patients

Ozawade is suitable for the treatment of adult patients with OSA to improve wakefulness and reduce EDS

The efficacy and safety of Ozawade in the treatment of EDS in patients with OSA were evaluated in 2 phase 3 clinical studies (HAROSA I, HAROSA II)

The active pharmaceutical ingredient of Ozawade is pitolisant, which is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which increases the nerves that promote wakefulness in the brain by enhancing the activity of histaminergic neurons The synthesis and release of the transmitter histamine improves the patient's wakefulness and alertness

pitolisant was approved for marketing in the European Union and the United States in March 2016 and August 2019.

Pitolisant was developed by Bioprojet.

According to an announcement issued by Langyu Group, on May 7 this year, Wakix® issued the first domestic prescription at the Hainan Boao Yiling Life Quality Improvement Center

In July of this year, Langyu Group submitted a new drug listing application (NDA) for Wakix® (pitolisant) to the National Medical Products Administration (NMPA) for the treatment of narcolepsy with or without cataplexy

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Original source: EMA nod for excessive daytime sleepiness med Ozawade