Takeda nets first-in-class advantage on narcolepsy drug’s FDA go-ahead

The US Food and Drug Administration (FDA) has approved Takeda's oveporexton, marketed as Orzeyful, for the treatment of narcolepsy type 1. This is the first drug of its class – an orexin receptor agonist – taken twice daily and designed for patients with type 1 narcolepsy, a chronic sleep disorder characterized by daytime sleepiness, sudden muscle weakness, and other symptoms including disrupted nighttime sleep, hallucinations, and sleep paralysis. The approval was based on Phase III clinical trials FirstLight and RadiantLight, in which the drug significantly improved patients' ability to stay awake during the day compared to placebo. Unlike current treatments that only manage individual symptoms, Orzeyful targets the root cause of type 1 narcolepsy by binding to orexin receptor 2, which regulates wakefulness and sleep-wake cycles. Takeda expects the drug to receive controlled substance classification from the DEA within 90 days, after which it will be available through specialty pharmacies.