拜耳(BAYRY.US)在研疗法elinzanetant递交上市申请

智通财经08-02

智通财经APP获悉，8月2日，拜耳(BAYRY.US)宣布，已向美国FDA提交了一份新药申请(NDA)，寻求批准在研疗法elinzanetant用于治疗与更年期相关的中度至重度血管运动症状(VMS，也称为潮热)。这一申请是基于3期临床研究OASIS 1、2和3的积极疗效和安全性结果。此前发布的研究结果显示，在OASIS 1和2两项研究中，elinzanetant成功达到所有四个主要终点。OASIS...

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