Esperion的非他汀类口服片剂NILEMDO,获欧洲批准治疗高胆固醇血症和混合性血脂异常

2020-04-07 MedSci原创 MedSci原创

NILEMDO的批准得到关键的3期临床试验数据支持,该研究共涉及3600多名患者。与安慰剂相比, NILEMDO可使LDL-C降低多达28%。

Esperion宣布,欧盟委员会批准了NILEMDO(bempedoic acid)每日一次的非他汀类口服片剂,用于降低LDL胆固醇(LDL-C)。NILEMDO作为ATP柠檬酸裂解酶(ACL)抑制剂,可通过抑制肝脏中的胆固醇合成来降低LDL-C。

欧盟委员会批准NILEMDO与他汀类药物与其他降脂疗法联合,用于他汀类药物的最大耐受剂量无法达到LDL-C标准的患者;和单独或与其他降脂疗法联合,用于不能接受他汀类药物的患者,以治疗原发性高胆固醇血症(家族性和非家族性杂合子)或混合性血脂异常的成人。

Esperion总裁兼首席执行官Tim M. Mayleben说:"欧洲的数百万患者需要每天服用非他汀类药物,以帮助他们降低LDL-C。对于那些需要非他汀类药物的患者来说,NILEMDO可以单独使用也可以与他汀类药物联合使用。"

欧洲心脏病学会和欧洲动脉粥样硬化学会强烈建议通过降低LDL-C水平来降低心血管风险。即使到了今天,接受了他汀类药物治疗后仍有高达80%的患者未达到推荐的LDL-C水平,并且患心脏病或中风的风险增加。NILEMDO为患者及其医生提供了重要的新型口服,非他汀类药物的选择。

NILEMDO的批准得到关键的3期临床试验数据支持,该研究共涉及3600多名患者。与安慰剂相比, NILEMDO可使LDL-C降低多达28%。

原始出处:

https://www.firstwordpharma.com/node/1713585?tsid=4

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    2020-09-23 shenxlcyp
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    2020-09-24 feather89
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