FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy

The FDA has granted Priority Review to Roche's Gazyva/Gazyvaro (obinutuzumab) for treating primary membranous nephropathy (pMN), based on positive Phase III MAJESTY trial results showing 36.9% complete remission rate versus 5.7% with tacrolimus. If approved by November 2026, it would be the first FDA-approved therapy for pMN, a chronic autoimmune kidney disease affecting approximately 1.2 per 100,000 people annually in the US.