智通财经APP获悉，4月7日，CDE 官网显示，诺华制药(NVS.US)英克司兰钠注射液新适应症上市申请获受理。根据临床进展和公开资料，Insight 数据库推测该适应症为用于未接受任何降脂治疗的动脉粥样硬化性心血管疾病(ASCVD)中危或低危且低密度脂蛋白胆固醇(LDL-C)升高的成人患者。

截图来源：CDE官网

英克司兰钠是全球首款也是目前唯一一款降低 LDL-C的小干扰 RNA 药物，于2020 年、2021年分别获欧盟、FDA批准上市，用于治疗成人高胆固醇血症及混合性血脂异常，证明了小核酸药物在慢病领域的治疗潜力。截至目前，该药已经在包括美国、欧盟以及中国在内的近100个国家获得批准，在欧盟获批4项适应症，在美国获批3项适应症，在中国获批4项适应症。

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