诺华与英国NHS联合,以快速推进胆固醇PCSK9的基因干扰药物inclisiran

2020-01-16 不详 MedSci原创

诺华与英国国家医疗服务体系(NHS)建立了新的合作伙伴关系,该合作将使患者更快地获得其开创性的降低胆固醇药物inclisiran,诺华以97亿美元收购了开发该药物的Medicines公司。

诺华与英国国家医疗服务体系(NHS)建立了新的合作伙伴关系,该合作将使患者更快地获得其开创性的降低胆固醇药物inclisiran,诺华以97亿美元收购了开发该药物的Medicines公司。

Inclisiran是小型的干扰RNA(siRNA)基因沉默药物,通过阻断肝脏PCSK9的合成而发挥作用,并将作为大规模NHS临床试验的一部分在英国患者中进行研究。据卫生和社会保健部长Matt Hancock说,"这种合作有潜力在未来十年内挽救30000个生命"。

临床试验将利用NHS数据来识别全国范围内有心脏病风险并且在常规治疗方案(包括他汀类药物)中没有好转的患者。

在3期试验中,inclisiran能够显着降低LDL胆固醇的水平,并证明在治疗开始后3至18个月的各个时间点,LDL胆固醇的绝对变化。

它已被测试用于患有动脉粥样硬化性心血管疾病(ASCVD)的患者,尽管服用了他汀类药物的最大剂量仍无法控制其LDL胆固醇水平,无论是否使用默克公司的增效疗法Zetia(ezetimibe)。

卫生和社会保健部尚未透露获得该药物的商定价格,一旦获得欧洲药品管理局(EMA)的批准,英国的成本效益监察机构NICE将会加快审查的速度。届时,诺华将与NICE协商将inclisiran用于NHS的最终价格。

Inclisiran尚未在任何市场上获得批准,但已提交FDA进行审查,诺华表示,该药物也将在未来几周内提交给EMA。

原始出处:


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    2020-11-10 FukaiBao
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    2020-09-17 Tamikia
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    2020-01-18 小几洁

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