欧洲可能批准罗歇的“Gazyva”治疗严重的狼疮肾炎,表明肾脏结果较好,试验中使用类固醇较少。 Europe may approve Roche’s Gazyva for severe lupus nephritis, showing better kidney results and less steroid use in trials.

欧洲医药署的CHMP建议批准Roche的Gazyva/Gazyvaro, 加上用于治疗患有严重狼疮肾炎的成人病人的甲状腺酸甲酯和甲状腺素,其依据是第三阶段试验结果显示肾反应改善,类固醇使用减少。 The European Medicines Agency's CHMP has recommended approval of Roche’s Gazyva/Gazyvaro combined with mycophenolate mofetil for treating adult patients with severe lupus nephritis, based on phase III trial results showing improved kidney response and reduced steroid use. 该药物以B细胞为目标,其结果优于标准治疗。 The drug, which targets B cells, demonstrated better outcomes than standard therapy alone. 欧洲联盟委员会的最后决定尚待作出,而美国林业发展局预计今年将就类似的申请作出裁决。 A final decision by the European Commission is pending, while the U.S. FDA is expected to rule on a similar application this year. Lupus肾炎影响到全球170多万人,主要是有色妇女,并可能导致肾衰竭。 Lupus nephritis affects over 1.7 million people globally, primarily women of color, and can lead to kidney failure. 目前没有治疗办法。 There is currently no cure.