Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease

Core Insights - Roche's phase III MAJESTY study for Gazyva®/Gazyvaro® (obinutuzumab) in adults with primary membranous nephropathy met its primary endpoint, demonstrating significant results in achieving complete remission compared to tacrolimus [1][2] - The study indicates that Gazyva/Gazyvaro may help maintain kidney function longer and delay life-threatening complications, potentially becoming the first approved therapy for this condition [2][4] Study Results - The MAJESTY study showed that significantly more patients achieved complete remission at two years (104 weeks) with Gazyva/Gazyvaro compared to tacrolimus [1] - Key secondary endpoints also demonstrated statistically significant benefits in overall remission (complete or partial) at week 104 and complete remission at week 76 [2] Patient Impact - Primary membranous nephropathy affects nearly 88,000 people in the EU and over 96,000 in the US, with up to 30% progressing to kidney failure within 10 years [4][10] - Achieving complete remission is critical to maintaining kidney function and preventing serious complications, which can have significant impacts on patients and healthcare systems [4][10] Previous Studies - The MAJESTY study is the fourth positive phase III study for Gazyva/Gazyvaro in immune-mediated diseases, following studies in lupus nephritis and systemic lupus erythematosus [5] - This growing body of evidence supports the drug's potential across a spectrum of immune-mediated diseases [5] Regulatory Pathway - Data from the MAJESTY study will be presented at medical meetings and shared with health authorities, including the US FDA and the European Medicines Agency [3]