FDA approves Takeda narcolepsy drug, signaling a new era for orexin-based therapies
The FDA approved Takeda’s Orzeyful, a twice-daily orexin receptor agonist for narcolepsy type 1, a first-in-class treatment that improved daytime wakefulness and reduced sleepiness in Phase 3 trials, offering potential benefits over current therapies and hinting at broader neurological applications, though long-term safety and applicability remain under study.