ProKidney公司宣布与美国食品药品监督管理局（FDA）就加速审批路径达成共识。FDA确认eGFR斜率可作为Rilparencel疗法针对慢性肾病合并2型糖尿病患者的替代终点。该药物的加速审批关键数据预计将于2027年第二季度公布。值得关注的是，FDA确认其第三阶段PROACT 1研究结果既可支持加速审批，也可用于全面批准申请。
ProKidney公司宣布与美国食品药品监督管理局（FDA）就加速审批路径达成共识。FDA确认eGFR斜率可作为Rilparencel疗法针对慢性肾病合并2型糖尿病患者的替代终点。该药物的加速审批关键数据预计将于2027年第二季度公布。值得关注的是，FDA确认其第三阶段PROACT 1研究结果既可支持加速审批，也可用于全面批准申请。
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