金吾财讯 | 拜耳（BAYRY）宣布，美国食品药品监督管理局（FDA）已批准其非甾体盐皮质激素受体拮抗剂（MRA）可仁达®（KERENDIA®，通用名：非奈利酮/finerenone）的新适应症申请，用于降低伴有1型糖尿病（T1D）的慢性肾脏病（CKD）成人患者的尿白蛋白/肌酐比值（UACR），从而预期有望延缓肾脏疾病进展及终末期肾病风险。本次获批使可仁达®成为30多年来首个获批用于治疗1型糖尿病相关慢性肾脏病的创新疗法。根据关键III期FINE-ONE临床试验数据，在标准治疗的基础上，可仁达®在治疗6个月时将患者UACR显著降低了28%（p=0.0001），且安全性与既有数据一致。此前该药已获批用于治疗2型糖尿病（T2D）相关慢性肾脏病，以及左心室射血分数（LVEF）≥40%的心力衰竭患者。这是FDA批准该药的第三个适应症，进一步奠定了其在心肾并发症治疗领域的市场地位。拜耳方面表示，可仁达®作为目前唯一获批可同时覆盖1型和2型糖尿病相关慢性肾脏病的口服每日一次MRA药物，将有效填补长期以来的临床空白，并持续巩固公司在心血管及肾脏疾病领域的全球领跑优势。
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