Home / Health / Japan Approves Takeda's Orzeyful for Narcolepsy
Japan Approves Takeda's Orzeyful for Narcolepsy
25 Aug
Summary
- Orzeyful is the only Japan treatment for narcolepsy type 1's root cause.
- This oral orexin receptor 2 agonist was discovered in Takeda's Japan labs.
- The drug is already approved in China and the United States.
Takeda has secured approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Orzeyful (oveporexton) to treat narcolepsy type 1 in adults. This decision positions Orzeyful as the sole treatment in Japan that targets the root cause of narcolepsy type 1, also known as narcolepsy with cataplexy.
Discovered in Japan within Takeda's own laboratories, Orzeyful is an oral orexin receptor 2 agonist. Takeda is actively preparing for the drug's launch in Japan, aiming to make it accessible to patients promptly. This marks the third global approval for Orzeyful, following earlier authorisations in China and the United States.
The MHLW approval was supported by robust clinical trial data, including the global Phase III FirstLight and RadiantLight trials. These studies demonstrated Orzeyful's efficacy in improving excessive daytime sleepiness, cataplexy, and other symptoms compared to placebo. The drug's safety profile was consistent across trials, with common adverse events including insomnia and urinary urgency.
Narcolepsy type 1 is a rare, chronic neurological disorder characterized by orexin deficiency, leading to symptoms such as excessive daytime sleepiness, cataplexy, and disturbed sleep. Takeda's President and CEO highlighted Orzeyful as a testament to Japan-originated science with global impact, validating their broader orexin strategy.
