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案卷号FDA-2021-P-1286 | Stat News
I.背景A. Entresto于2015年7月7日，FDA批准了Entresto（NDA 207620）“降低了慢性心力衰竭患者（NYHA II-II-IV类）和减少射血分数的患者心力衰竭的心血管衰竭的风险。” 2为了支持Entresto的原始指示批准，诺华进行了一项单一阶段临床试验，称为“ Paradigm-HF”。 3“ Paradigm-HF是一项跨国，随机的双盲试验，比较了8,442例有症状性慢性心力衰竭（NYHA II – II-IV）和收缩功能障碍（左心室射血分数[（LVEF）]的症状性慢性心力衰竭（NYHA II – II – IV）患者的Entresto和enalapril [（LVEF）]。补充018 5 2020年4月20日，请愿人提交了疗效补充（SNDA 207620/S-018），其中包括请愿人进行的3期临床试验的数据和结果，称为“ Paragon-HF”。 6 Paragon-HF是一项多中心，随机，双盲试验，比较了4,796名与L9（）DQG VWUXFWXUDO KHDUW GLVHDVH glvhdvh hlwkhu hlwkhu hlwkhu hlwkhu ohi ohi ohiw dwuldo hqodujhphqw ru ohii ohii ohii ohii hipyprofferfffffffffffffctement。7，2021年2月16日，FDA批准了SNDA 207620/S-018，以更新到Entresto标签，包括与Paragon-HF试验有关的更改。补充批准对指示和用法（1.1）和临床研究（14.1）部分进行了实质性修订，并在整个标签中也进行了其他修订。8 Entresto目前为以下指示：
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