Takeda launches ORZEYFUL in Japan and China for narcolepsy type 1

Takeda has launched ORZEYFUL, also known as oveporexton, in Japan and China for the treatment of narcolepsy type 1.

The launch gives physicians in both markets access to the first-in-class orexin receptor 2 agonist following recent regulatory approvals.

ORZEYFUL was approved within a month by China’s National Medical Products Administration, the U.S. Food and Drug Administration and Japan’s Ministry of Health, Labour and Welfare.

Takeda said the medicine is expected to launch in the U.S. next month following completion of Drug Enforcement Administration scheduling.

Regulatory submissions are also progressing in additional markets worldwide.

ORZEYFUL is an oral orexin receptor 2 agonist designed to restore orexin signalling in people with narcolepsy type 1.

The condition is caused by orexin deficiency and can lead to excessive daytime sleepiness, cataplexy, disrupted nighttime sleep, sleep paralysis, hallucinations and cognitive symptoms.

Takeda said the treatment represents a shift from managing individual symptoms toward targeting the underlying biological cause of the disease.

Giles Platford, President of Takeda International, said the launch in Japan and China could change the way narcolepsy type 1 is managed by providing a treatment directed at the core orexin deficiency.

He said patients have reported improvements in daily functioning and quality of life during clinical development.

ORZEYFUL was discovered by Takeda scientists in Japan and is the lead medicine in the company’s broader orexin development programme.

The company is investigating additional orexin-based treatments across sleep-wake disorders and other conditions where orexin biology may play a role.

Phase III studies in patients with narcolepsy type 1 showed statistically significant and clinically meaningful improvements across several measures compared with placebo.

These included wakefulness, daytime sleepiness, cataplexy, overall disease severity and quality of life.

Improvements were observed from the earliest assessed time points and were maintained through 12 weeks of treatment.

Takeda said ORZEYFUL was generally well tolerated, with a safety profile consistent across clinical studies.

The most commonly reported side effects included insomnia, urinary urgency, increased urinary frequency and excessive saliva production.

The simultaneous commercial availability in Japan and China marks the first opportunity for physicians to prescribe the medicine outside clinical studies.

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