FDA批准Roche的Lupus肾炎Gazyva计划, 与标准疗法相结合, 肾脏恢复情况有所改善。 FDA approves Roche’s Gazyva for lupus nephritis, showing improved kidney recovery when combined with standard therapy.

根据试验显示脏反应率有所改善,FDA批准罗氏Gazyva (obinutuzumab) 治疗与标准治疗一起使用的活跃狼性炎的成年患者. The FDA has approved Roche’s Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis when used with standard therapy, based on trials showing improved kidney response rates. Gazyva加标准护理的患者近一半实现了完全的肾反应,而仅标准治疗就达到33.1%。 Nearly half of patients on Gazyva plus standard care achieved complete renal response, compared to 33.1% on standard treatment alone. 以B细胞为目标的该药物还减少了蛋白质尿和花生类固醇的使用。 The drug, which targets B cells, also reduced proteinuria and corticosteroid use. 在最初剂量后批准缩短90分钟的注入等待时间,以便每年进行两次治疗。 A shorter 90-minute infusion wait time was approved after initial doses, enabling twice-yearly treatments. Gazyva是首例帮助病人完全恢复肾功能的疗法。 Gazyva is the first therapy shown to help patients achieve full kidney recovery. 欧洲药品局正在审查该药物,以供批准。 The European Medicines Agency is reviewing the drug for approval.