PraluentPraluent(通用名Alirocumab)是由赛诺菲和再生元合作开发,于2015年7月24日获得FDA批准上市。2019年12月28日,获得NMPA批准上市,适应症为原发性高胆固醇血症(杂合子型家族性和非家族性)或混合性血脂异常的成年患者;降低动脉粥样硬化性心血管疾病(ASCVD)患者的心血管事件风险。一项ODYSSEY研究显示Alirocumab通过降低LDL-C等动脉粥样硬化脂蛋白显著降低中风和缺血性中风的风险,试验纳入18,924例(中国患者614例)患有ASCVD且LDL-C水平≥70mg/dL(1.8mmol/L)的病人,在他汀类药物治疗的基础上,Alirocumab治疗第4个月,LDL-C降低62.7%(37.6mg/dL VS 93.3mg/dL),第48个月时,LDL-C降低54.7%(53.3mg/dL VS 101.4mg/dL)。主要关键终点为不良心脏事件降低(MACE,包括冠心病死亡,急性心肌梗死,缺血性中风,不稳定型心绞痛),与安慰剂相比,MACE(9.5% VS 11.1%),HR0.85(95% CI,0.78-0.93),P<0.001。次要关键终点冠心病死亡,急性心肌梗死,缺血性中风风险降低,(10.3% VS 11.9%),P = 0.0003。但是2款药物上市后销售额未达到预期,一方面是监管机构对慢性病的安全性考量十分谨慎,保险公司对其限定患病人群;另一方面是上市以来其价格较高。2018年开始,为提高PCSK9抑制剂的市场份额,赛诺菲和安进先后展开价格战,从初始价格每年$14,000左右(Repatha,$14,100/年;Praluent,$14,600/年)将至$5850/年。
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