Gazyva在治疗肾病 -- -- 肾脏疾病 -- -- 初级中子肾脏病方面取得了显著成果,有可能成为第一个经核准的治疗方法。 Gazyva showed strong results in treating primary membranous nephropathy, a kidney disease, potentially becoming the first approved therapy for it.

Genentech报告说,由于MAJESTY试验,第三阶段取得了积极的成果,显示Gazyva(Obinutuzumab)大大改善了患有初级中子肾脏病(慢性自动免疫肾脏疾病)的成人的复发率。 Genentech reports positive Phase III results from the MAJESTY trial, showing Gazyva (obinutuzumab) significantly improved remission rates in adults with primary membranous nephropathy, a chronic autoimmune kidney disease. 治疗达到其初级终点,与Tacrolimus相比,完全恢复率更高,为两年,比Tacrolimus高,在关键的二级终点显示出显著的好处。 The treatment met its primary endpoint, with higher complete remission rates at two years compared to tacrolimus, and showed significant benefits in key secondary endpoints. 安全概况与已知数据保持一致,没有发现新的风险。 The safety profile remained consistent with known data, with no new risks identified. 如果得到批准,Gazyva将成为针对这一病症的首例疗法,影响到美国96,000多人,并有可能在十年内导致高达30%的肾衰竭。 If approved, Gazyva would be the first therapy specifically indicated for this condition, affecting over 96,000 people in the U.S. and potentially leading to kidney failure in up to 30% within ten years. 数据将提交给监管机构,包括林业发展局和EMA。 Data will be submitted to regulatory agencies including the FDA and EMA. Gazyva已被批准治疗狼疮肾炎,在100个国家用于治疗某些血癌。 Gazyva is already approved for lupus nephritis and used in 100 countries for certain blood cancers.