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Takeda Wins FDA Approval for First-in-Class Narcolepsy Treatment ORZEYFUL

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Takeda Pharmaceutical (TYO:4502) has secured U.S. FDA approval for ORZEYFUL (oveporexton), an oral orexin receptor 2 agonist, as the first treatment to holistically address narcolepsy type 1, according to a statement on Thursday.

The rare neurological disorder, which affects an estimated 120,000 Americans, is driven by orexin deficiency and causes excessive daytime sleepiness, cataplexy, cognitive issues and disrupted nighttime sleep.

The approval introduces a new class of medicine for NT1, potentially redefining disease management and patient outcomes, according to principal investigator Dr. Emmanuel Mignot.

Shares of Takeda rose nearly 2% in recent trade.

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