Shots:
- Takeda has reported data from 2 P-III (FirstLight & RadiantLight) trials assessing oveporexton over 12wks. in NT1 pts, where FirstLight randomized 168 pts in 3 arms (high dose, low dose & PBO), while RadiantLight randomized 105 pts in 2 arms (high dose & PBO)
- Both studies showed improvements across all doses at Wk. 12 in 1 & 2EPs, incl. wakefulness, EDS, cataplexy, attention, overall QoL, & daily functioning, achieving near normal ranges across broad range of symptoms
- Takeda will present data from both the trials at future medical conferences & plans NDA submission to the US FDA along with other global health authorities in 2025
Ref: Businesswire  | Image: Takeda| Press Release
Related News:-Â Takeda Reports US FDA Approval of GAMMAGARD LIQUID ERC for Primary Immunodeficiency
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