Takeda’s Orzeyful secured Japan MHLW approval for narcolepsy type 1

This decision makes Orzeyful the only treatment in Japan currently indicated to address the underlying cause of narcolepsy type 1, also known as narcolepsy with cataplexy, rather than targeting individual symptoms.

Orzeyful, an oral orexin receptor 2 agonist, was discovered in Takeda’s laboratories in Japan.

Takeda is preparing to launch the therapy in Japan, aiming to make it available to patients as soon as possible.

Takeda president and CEO Julie Kim said: “Our discovery of the first orexin agonist is a successful representation of Japan-originated science that will directly impact people around the world living with narcolepsy type 1.

“With the potential to redefine narcolepsy type 1 care, Orzeyful is the first validation of our broader orexin strategy, demonstrating how scientific innovation can create new possibilities for patients and drive future growth for Takeda.”

Narcolepsy type 1 is described as a chronic and rare neurological disorder involving a deficiency of orexin.

Symptoms can include excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disturbed night-time sleep, sleep paralysis, hallucinations, and cognitive issues.

The MHLW approval was supported by results from a clinical programme, including the global Phase III FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) trials.

These studies reported that oveporexton improved excessive daytime sleepiness, cataplexy, and other secondary symptoms compared to placebo.

The safety profile was consistent across studies, with the most frequent adverse events being insomnia, urinary urgency, urinary frequency, and excessive saliva.

The Japanese approval is the third for Orzeyful worldwide, following earlier authorisations for the treatment of narcolepsy type 1 in China and the US.

In the US, the classification of Orzeyful as a controlled substance remains under review by the Drug Enforcement Administration.

Last month, Insilico Medicine entered a strategic collaboration agreement with Takeda to deploy its AI-based Pharma.AI platform in the discovery and development of drug candidates.

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