Roche’s Gazyva/Gazyvaro Shows Positive Phase III Results in Primary Membranous Nephropathy

Roche announced that its phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, with significantly more patients achieving complete remission at two years using Gazyva®/Gazyvaro® (obinutuzumab) compared to tacrolimus. The safety profile remained consistent with previous findings, and no new safety concerns emerged.

Advancing Treatment Options for Rare Kidney Disease

Primary membranous nephropathy is a chronic autoimmune condition affecting nearly 88,000 people in the EU and over 96,000 in the US, with up to 30% progressing to kidney failure within a decade. Gazyva/Gazyvaro targets the underlying disease mechanism, offering the potential to maintain kidney function and prevent life-threatening complications where limited therapies currently exist.

Expanding Roche’s Immunology Portfolio

MAJESTY marks the fourth positive phase III trial of Gazyva/Gazyvaro in immune-mediated diseases, following successes in lupus nephritis, systemic lupus erythematosus, and idiopathic nephrotic syndrome. The results reinforce Roche’s strategy to lead in immunology, particularly in immune-mediated and kidney-related disorders.