Japanese pharmaceutical company Takeda (TSE:4502) (NYSE:TAK) said on Tuesday that the the US Food and Drug Administration (FDA) has accepted its New Drug Application and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1.

The FDA has set a Prescription Drug User Fee Act target action date in the third quarter of this calendar year, positioning oveporexton as a potential first-in-class orexin agonist therapy.

Oveporexton is an investigational oral orexin receptor 2-selective agonist designed to restore orexin signalling and address the underlying deficiency that causes narcolepsy type 1.

The NDA is supported by data from the global Phase 3 FirstLight and RadiantLight studies, which showed statistically significant and clinically meaningful improvements across wakefulness, excessive daytime sleepiness, cataplexy, attention, quality of life and daily functioning. Takeda reported that outcomes approached near-normal ranges across the symptoms evaluated. Oveporexton was generally well tolerated, with insomnia, urinary urgency and urinary frequency reported as the most common adverse events.

The therapy has previously received Breakthrough Therapy designation in the United States and China, as well as Sakigake designation in Japan.