Japanese pharmaceutical company Takeda (TSE:4502) (NYSE:TAK) announced on Monday that Japan's Ministry of Health, Labour and Welfare has approved ORZEYFUL (oveporexton) for adults with narcolepsy type 1 (NT1, narcolepsy with cataplexy), marking the drug's third major regulatory approval globally.

ORZEYFUL is an oral orexin receptor 2 agonist and the first and only medicine approved in Japan to treat NT1 holistically rather than individual symptoms, according to Takeda.

The approval is supported by Phase 3 FirstLight and RadiantLight studies, which showed statistically significant improvements across the full range of NT1 symptoms assessed, including excessive daytime sleepiness and cataplexy. Takeda said oveporexton was generally well tolerated, with a consistent safety profile across clinical studies.

NT1 is a rare neurological disease driven by orexin deficiency that can cause daytime and nighttime symptoms and significantly affect work, education and social interactions.

Takeda said it is preparing for the Japanese launch and plans to make ORZEYFUL available as quickly as possible.