Vera Therapeutics：TRUTAKNA ORIGIN 3 最终分析显示 eGFR 稳定，肾脏进展风险降低 76%

ORIGIN 3 最终疗效分析（n=428）达到所有预设终点，证明了真正的 eGFR 稳定，并在两年内将复合肾脏疾病进展事件减少 76%。Vera 计划基于这些确证性结果于 2026 年 Q4 提交补充 BLA 以获得完全批准。

关键事实

申报时间: 2026年9月15日 10:45
事件: 顶线结果
方向: 积极
公司: VERAVera Therapeutics
资产: atacicept
来源: SEC 8-K
可信度: 有来源
第52周eGFR变化: -0.1 vs -5.7 mL/min/1.73m² (p<0.0001)
104 周 EGFR 斜率: -0.6 vs -5.6 mL/min/1.73m²/年 (p<0.0001)
复合进展 HR: 0.24 (风险降低 76%, p<0.0001)
透析移植死亡: 0 vs 8 例事件

来源摘录

EX-99.1 2 d32300dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Vera Therapeutics Announces TRUTAKNA ™ (atacicept-vymj) Stabilized eGFR and Prevented Kidney Disease Progression Through Two Years in ORIGIN 3 Final Efficacy Analysis in IgA Nephropathy • TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, met all prespecified endpoints, including unprecedented placebo-adjusted estimated glomerular filtration rate (eGFR) and composite kidney disease progression benefits. • Favorable safety profile, and generally comparable to placebo. • Strong commercial launch momentum with over 350 patient start forms generated in the first ten weeks. • Plan to submit supplemental BLA to the U.S. Food and Drug Administration (FDA) for full approval in Q4 2026. BRISBANE, Calif., September

SEC 8-K