智通财经APP获悉，罗氏(RHHBY.US)今天宣布，美国FDA已接受该公司为抗CD20抗体obinutuzumab递交的补充生物制品许可申请(sBLA)，用于治疗狼疮性肾炎。FDA预计在2025年10月前完成审评。新闻稿指出，obinutuzumab是首个在狼疮性肾炎随机3期临床试验中显示出完全肾脏缓解(CRR)益处的抗CD20单克隆抗体。
Obinutuzumab是一种抗CD20人源化单克隆抗体，CD20是某些类型B细胞表达的蛋白质。在狼疮性肾炎中，致病B细胞驱动持续性炎症，从而损伤肾脏。通过使用obinutuzumab耗竭致病B细胞，可针对狼疮性肾炎的根本原因，以帮助更好地控制该疾病，保护肾脏免受进一步损伤，并可能预防或延缓疾病进展至终末期肾病。
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