礼来的CGRP抑制剂Emgality喜获FDA批准,成为阵发性丛集性头痛的治疗药物

2019-06-05 不详 MedSci原创

美国食品和药物管理局批准将礼来的降钙素基因相关肽(CGRP)抑制剂Emgality(galcanezumab-gnlm),用于治疗成人阵发性丛集性头痛。

美国食品和药物管理局批准将礼来的降钙素基因相关肽(CGRP)抑制剂Emgality(galcanezumab-gnlm),用于治疗成人阵发性丛集性头痛。

FDA药物评估和研究中心神经病学产品部副主任Eric Bastings表示:"Emgality是FDA第一个批准的药物,可以减少阵发性丛集性头痛的发作频率。"

涉及106名患者的研究结果显示,在三周期间,给予Emgality的患者每周集群头痛发作的次数比基线时少8.7次,而安慰剂组患者的发作次数减少5.2次。

Emgality最初由FDA去年九月批准用于成人偏头痛的预防性治疗。

原始出处:


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    2019-08-12 jklm09
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    2019-10-08 gostraight
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FDA或将批准CGRP抑制剂eptinezumab以预防偏头痛

Alder Bio生物制药公司近日宣布已提交研究性CGRP抑制剂eptinezumab的申请,以获得FDA的批准用于预防偏头痛。该制药商表示,如果得到FDA的批准,eptinezumab可能会在明年第一季度上市。Alder Bio首席执行官Bob Azelby指出,eptinezumab将成为第一个专门用于快速、有效和持续抑制偏头痛的季度输液疗法。