维拉治疗公司向FDA提交了一份药物申请,申请使用Igan的潜在治疗方法atacicept,该药物在试验中显著减少了蛋白尿. Vera Therapeutics submitted a drug application to the FDA for atacicept, a potential treatment for IgAN, showing significant proteinuria reduction in trials.

根据加速批准计划,Vera Therapeutics已向FDA提交了一份生物制品许可申请,申请用于治疗免疫球蛋白A瘤 (IgAN) 的研究治疗方法. Vera Therapeutics has submitted a Biologics License Application to the FDA for atacicept, an investigational treatment for immunoglobulin A nephropathy (IgAN), under the Accelerated Approval Program. 提交资料的依据是第3阶段ORIGIN试验数据,该数据表明,从基准量起蛋白质尿素减少了46%,与第36周的安慰剂相比减少了42%,具有统计意义。 The submission is based on Phase 3 ORIGIN trial data showing a 46% reduction in proteinuria from baseline and a 42% reduction versus placebo at week 36, with statistical significance. Atacyception,每周一次注射,针对BAFF和APRIL, 与IgAN有关的蛋白质。 Atacicept, a subcutaneous weekly injection, targets BAFF and APRIL, proteins linked to IgAN. 它获得了 " 突破治疗 " 指认,如获批准,将成为该疾病的首个双向BAFF/APRIL抑制剂。 It received Breakthrough Therapy Designation, and if approved, would be the first dual BAFF/APRIL inhibitor for the disease. 预计FDA将在2026年作出决定. The FDA is expected to make a decision in 2026.