临床和经济评论研究所(ICER):PCSK9抑制剂Alirocumab治疗高胆固醇症的证据更新

2019-02-19 不详 网络

临床和经济评论研究所(ICER)近日发布了Alirocumab(Praluent®)的证据更新,这是一种可注射的PCSK9抑制剂,用于治疗某些患者人群中的高胆固醇。此次证据更新是基于对ODYSSEY试验结果的进一步分析,该试验现已经过同行评审,并于2018年11月7日在新英格兰医学杂志上发表。

临床和经济评论研究所(ICER)近日发布了AlirocumabPraluent®)的证据更新,这是一种可注射的PCSK9抑制剂,用于治疗某些患者人群中的高胆固醇。此次证据更新是基于对ODYSSEY试验结果的进一步分析,该试验现已经过同行评审,并于2018117日在新英格兰医学杂志上发表。

根据这些新的分析,ICER正在将Alirocumab的基于价值的价格基准范围修改为每年2,300-3,500美元,但对于LDL胆固醇LDL-C≥100mg/ dL的患者,基于价值的价格基准范围应为每年2,7004,000美元。值得注意的是,再生元公司和赛诺菲公司最近宣布,Alirocumab的年度美国定价将降至5,850美元,低于该药物于2015年首次推出时的14,600美元。

PCSK9是一种肝源性分泌蛋白,PCSK9作为一种神经细胞凋亡调节转化酶,不但参与肝脏再生,调节神经细胞凋亡,还能通过降低肝细胞上LDLR的数量,影响 LDL的内化,使血液LDL不能清除,从而导致高胆固醇血症。


原始出处:

http://www.firstwordpharma.com/node/1625473?tsid=4#axzz5fsFeuq5D

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    2019-07-29 FukaiBao
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    2019-11-15 jklm09
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    2020-02-03 Tamikia
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    2020-01-01 chenwq08
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    2019-10-14 snf701207
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    2019-12-30 linlin2312
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由此可见,在研究各组间,alirocumab相关的LDL-C、载脂蛋白B和non-HDL-C的减少更显著,相比于对照组,而没有被Mets的状态所改变。

新型降脂药Alirocumab获FDA批准和欧洲CHMP批准建议

正如业内广泛预期,6月24日新型降低密度脂蛋白胆固醇(LDL-C)药物Alirocumab(Praluent)获得美国食品与药物管理局(FDA)批准。该药的适应证为杂合子家族性高胆固醇血症的治疗或他汀治疗无效的心血管高危人群。 alirocumab是第一个获得FDA批准的PCSK9抑制剂,尽管业内广泛预期FDA会在接下来几周之内批准另一种PCSK9抑制剂evolocumab。据heartwire