Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)
Shots:
- The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26
- NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts
- Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention, overall QoL, & daily functioning, achieving near normal ranges across a broad range of symptoms
Ref: Businesswire | Image: Takeda | Press Release
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