拜耳(BAYRY)新药获FDA优先审评肾科用药版图扩容

金吾财讯

May 21

金吾财讯 | 拜耳(BAYRY)宣布，其肾病治疗药物 Kerendia（非奈利酮）的补充新药申请获美国 FDA 受理并授予优先审查资格，用于治疗 1 型糖尿病相关慢性肾病成年患者。此举有望进一步拓宽该药物的临床应用场景，强化拜耳在心肾治疗领域的布局。

此次申请基于关键 III 期 FINE-ONE 研究数据。结果显示，非奈利酮可显著降低患者尿白蛋白与肌酐比值，这一指标是评估 1 型糖尿病合并慢性肾病患者肾脏事件的核心预测因子Bayer。相关研究成果已于今年 3 月发表于《新英格兰医学杂志》，为药物有效性提供权威医学支撑。

Kerendia 当前已在美国获批用于两大适应症，涵盖 2 型糖尿病相关慢性肾病，以及左心室射血分数不低于 40% 的心力衰竭患者。作为高选择性非甾体盐皮质激素受体拮抗剂，其通过抑制受体过度激活，延缓肾脏纤维化进程，此前已在全球超 70 个国家和地区获批上市Bayer。

若本次新适应症顺利获批，Kerendia 将成为首款针对 1 型糖尿病相关慢性肾病的盐皮质激素受体拮抗剂，填补临床治疗空白。优先审查资格意味着 FDA 将加速审批流程，市场对其后续落地进度保持密切关注。

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