Key facts
- The U.S. FDA approved Takeda Pharmaceuticals' oral drug Orzeyful for narcolepsy type 1.
- Orzeyful is the first treatment approved to target the loss of orexin signaling, a cause of narcolepsy type 1.
- The drug is a twice-daily pill.
- Clinical studies showed patients taking Orzeyful had improved daytime wakefulness compared to placebo.
- The DEA is reviewing Orzeyful's controlled substance classification, with a decision expected in 90 days.
The U.S. Food and Drug Administration has approved Takeda Pharmaceuticals' oral drug, Orzeyful, for the treatment of narcolepsy type 1. This marks the first approved medication that directly targets the loss of orexin signaling, a chemical messenger responsible for regulating wakefulness, which is the underlying cause of the rare sleep disorder.