TOKYO (dpa-AFX) - Takeda Pharmaceutical Company Limited (TAK) said Tuesday that the U.S. Food and Drug Administration has accepted its new drug application for oveporexton and granted Priority Review for the treatment of narcolepsy type 1.
The agency set a Prescription Drug User Fee Act goal date in the third quarter of this calendar year.
Narcolepsy type 1 is a chronic, rare neurological disorder marked by excessive daytime sleepiness and cataplexy, or sudden loss of muscle tone.
The application is supported by positive data from the Phase 3 FirstLight and RadiantLight studies.
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