TOKYO (dpa-AFX) - Takeda Pharmaceutical Company Limited (TKPHF.PK) Monday said its two Phase 3 studies of oveporexton in narcolepsy type 1 (NT1) met primary endpoints.
NT1 is a chronic, rare neurological disease characterized by excessive daytime sleepiness, cataplexy, disrupted nighttime sleep, sleep paralysis and hallucinations upon falling asleep or waking.
In the two Phase 3 studies dubbed FirstLight and RadiantLight, oveporexton showed statistically significant improvements compared to placebo for all primary and secondary endpoints including improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions.
Takeda intends to submit a New Drug Application with the United States Food and Drug Administration (FDA) and other global regulatory authorities in fiscal 2025.
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