- FDA accepted Takeda's NDA for oveporexton, an orexin receptor 2-selective agonist.
- The PDUFA target action date is set for Q3 of this calendar year.
- Oveporexton addresses orexin deficiency causing narcolepsy type 1.
FDA Review
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Takeda's oveporexton (TAK-861) and granted it Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is set for the third quarter of this calendar year.
Oveporexton's Mechanism
Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist. It is designed to address the underlying orexin deficiency that causes narcolepsy type 1 (NT1) by restoring orexin signaling.
Narcolepsy Type 1
NT1 is a chronic, rare neurological disease characterized by excessive daytime sleepiness and cataplexy, resulting from a loss of orexin. This condition affects various aspects of life, including work, education, and social interactions. Despite existing therapies, many patients continue to experience symptoms.
