Takeda Pharmaceutical Company Limited
Acceptance of New Drug Application for Oveporexton (TAK-861), a Potential First-in-Class Treatment for Narcolepsy Type 1, by the U.S. Food and Drug Administration and Designation for Priority Review
Takeda Pharmaceutical has announced that the FDA has accepted the new drug application for oveporexton, a treatment for narcolepsy type 1, and designated it for priority review. The target date for review completion is Q3 2026.
Key Figures
- FDA acceptance of new drug application and designation for priority review
- Target review completion date: Calendar Q3 2026 (July-September)
- Minimal impact on FY March 2026 earnings forecast
AI要約
Overview of New Drug Application
Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for oveporexton (TAK-861), a potential first-in-class treatment for narcolepsy type 1 (NT1), and designated it for priority review. The target date for review completion is set for calendar Q3 2026 (July-September). Oveporexton is an orexin 2 receptor selective agonist and a novel oral therapy addressing orexin deficiency, the root cause of NT1.
Clinical Trial Results and Future Outlook
This application is based on comprehensive data from the global Phase 3 clinical trials FirstLight and RadiantLight, demonstrating statistically and clinically significant improvements across multiple domains including wakefulness, excessive daytime sleepiness, cataplexy, sustained attention, and quality of life (QOL). The safety profile was favorable, with primary adverse events including insomnia, urinary urgency, and frequency. Takeda plans to advance efforts to deliver the drug to NT1 patients upon approval. The impact of this application on the full-year consolidated earnings forecast for FY March 2026 is expected to be minimal.
