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欧盟批准将Evenity(romosozumab)用于治疗绝经后妇女的骨质疏松症

2019-12-16 不详 MedSci原创

欧盟委员会(EC)已授予Evenity(romosozumab)营销授权,用于治疗具有高风险骨折的绝经后妇女严重的骨质疏松症。

欧盟委员会(EC)已授予Evenity(romosozumab)营销授权,用于治疗具有高风险骨折的绝经后妇女严重的骨质疏松症。

Evenity是一款单抗药物,可抑制骨硬化蛋白(sclerostin)的活性,从而同时加速骨形成并减少骨吸收。骨硬化蛋白是一种分泌性糖蛋白。

生产该药的Amgen和UCB进行了一项开发计划,其中包括19项临床研究,招募了约14000名患者。

Amgen研发执行副总裁David Reese博士说:"对于需要在12个月内迅速增加骨矿物质密度的患者来说,该药物对于骨质疏松症的管理是重要一步。EC的批准可以使欧盟数百万高骨折风险女性可以使用这种疗法。"

UCB骨负责人兼执行副总裁Pascale Richetta博士说:"Evenity的批准可以为患者和临床医生提供一种新药,有助于推动继发性骨折预防方面的积极变化。"

预计该药物将于2020年上半年首次投放市场。

原始出处:


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    2019-12-19 snf701207
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    2020-06-25 jiyangfei
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    2019-12-18 Eleven17
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    2019-12-18 zxxiang

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