Roche announced that the FDA has granted Priority Review for Gazyva/Gazyvaro (obinutuzumab) to treat primary membranous nephropathy (pMN). This decision is based on positive Phase III MAJESTY study results, showing superior efficacy over tacrolimus in adults with pMN. Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years (36.9%) compared to tacrolimus (5.7%). If approved, Gazyva/Gazyvaro would be the first FDA-approved therapy for pMN, a chronic autoimmune kidney disease. Untreated pMN can lead to kidney failure in up to 30% of patients within ten years. The FDA has also granted Breakthrough Therapy Designation for Gazyva/Gazyvaro in pMN and expects an approval decision by November 2026. This is the second priority review for Gazyva/Gazyvaro this year, following idiopathic nephrotic syndrome. The drug targets tissue-resident B cells, addressing an underlying cause of pMN to help maintain kidney function. Safety results were consistent with Gazyva/Gazyvaro’s known profile. These data have been submitted to other global health authorities, including the European Medicines Agency.