Takeda Announced Topline Data From SKYLINE And SKYWAY Phase 3 Studies Of Soticlestat (TAK-935) Plus Standard Of Care Versus Placebo Plus Standard Of Care For Refractory Dravet Syndrome, Both The Studies Missed Their Primary Endpoints
Takeda Announced Topline Data From SKYLINE And SKYWAY Phase 3 Studies Of Soticlestat (TAK-935) Plus Standard Of Care Versus Placebo Plus Standard Of Care For Refractory Dravet Syndrome, Both The Studies Missed Their Primary Endpoints
武田宣佈SKYLINE和SKYWAY第3期Soticlestat (TAK-935)與標準板治療相比與安慰劑加標準板治療在難治性Dravet綜合症方面均未達到主要終點。
- SKYLINE Study in Dravet Syndrome Narrowly Missed its Primary Endpoint of Reduction in Convulsive Seizure Frequency and Showed Clinically Meaningful and Nominally Significant Effects in Multiple Key Secondary Efficacy Endpoints
- SKYWAY Study in Lennox-Gastaut Syndrome Missed its Primary Endpoint of Reduction in Major Motor Drop Seizures
- Soticlestat Showed a Consistent and Favorable Safety and Tolerability Profile in Both Studies
- Takeda Will Move Forward to Discuss the Totality of the Data with Regulatory Authorities
- SKYLINE研究在Dravet綜合徵方面未能達到主要終點——減少抽搐發作的頻率，並在多項關鍵二級療效終點上顯示出臨床意義和名義上的顯著效應。
- SKYWAY研究在Lennox-Gastaut綜合徵方面未能達到主要終點——減少重大運動障礙性抽搐的頻率。
- Soticlestat在兩項研究中顯示出一致且良好的安全性和耐受性。
- 武田將與監管機構繼續討論數據的總體情況。
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