阿斯利康周三表示，美国食品药品监督管理局已对其用于成人免疫球蛋白A肾病（IgA肾病）的治疗获得加速批准。该疾病是一种罕见的肾脏疾病，可能导致肾功能衰竭。以下是更多细节：阿斯利康称，治疗药物Ultomiris在晚期试验的中期分析中，较安慰剂在34周后将蛋白尿（尿中蛋白过多）降低了43.4%。该药企表示，FDA在其加速通道下授予了批准，且正在进行的试验将持续至106周，以确定Ultomiris是否能够减缓肾功能丧失，从而支持传统批准。
AstraZeneca said on Wednesday the US Food and Drug Administration granted accelerated approval for its treatment for adults with immunoglobulin A nephropathy, a rare kidney disease that can lead to renal failure. Here are more details:
公司还称，该药物是首个也是唯一获批用于该疾病的C5抑制剂，靶向与肾脏炎症相关的免疫系统通路。
阿斯利康表示，美国有超过20万人患有该疾病，其中约一半的患者尿蛋白水平升高或肾功能下降，面临在10年内出现肾衰竭的高风险。公司称，研究中未发现新的安全性问题，且该药物的申请也正在日本及其他国家审查中。
AstraZeneca said the treatment Ultomiris reduced proteinuria — excess protein in the urine — by 43.4% compared with placebo after 34 weeks in an interim analysis of the late-stage trial The drugmaker said the FDA granted the approval under its accelerated pathway, and that the ongoing trial will continue through 106 weeks to determine whether Ultomiris slows loss of kidney function to support traditional approval The company also said the drug was the first and only approved C5 inhibitor for the disease, targeting an immune-system pathway linked to kidney inflammation AstraZeneca said more than 200,000 people in the United States have the condition, and about half of those with elevated urine protein levels or reduced kidney function are at high risk of kidney failure within 10 years The company said no new safety concerns were identified in the study and applications are also under review in Japan and other countries