Bayer的Asundexian在试验中减少了经常性中风风险,达到了关键的目标。
Bayer's Asundexian reduced recurrent stroke risk in trial, meeting key goals.
Bayer报告说,对其药物Asundexian进行第3阶段试验取得了积极成果,表明用于抗塑胶疗法的经常缺血性中风风险显著降低,既达到了主要功效目标,也实现了安全目标。
Bayer reported positive results from a Phase 3 trial of its drug Asundexian, showing it significantly reduced recurrent ischemic stroke risk when used with antiplatelet therapy, meeting both primary efficacy and safety goals.
该药物是在以前非心血管中风的病人中测试的,从美国林业发展局获得快车道指认,有可能加快其审查速度。
The drug, tested in patients with prior non-cardioembolic ischemic strokes, received Fast Track designation from the U.S. FDA, potentially speeding its review.
Bayer计划与全球卫生当局讨论提交监管文件的问题,并将在一次科学会议上提交全部数据。
Bayer plans to discuss regulatory submissions with global health authorities and will present full data at a scientific conference.