Why did the FDA approve Takeda’s Orzeyful for narcolepsy type 1?

The FDA approved Takeda’s Orzeyful (oveporexton) for adults with narcolepsy type 1 because studies showed it improved daytime wakefulness, reduced sleepiness and cataplexy, and helped other core symptoms. The agency also highlighted it as the first drug to treat the disorder as a whole by directly restoring orexin signaling.