Roche's Gazyva Receives Priority FDA Review for Kidney Disease Treatment

The U.S. Food and Drug Administration has granted Priority Review status to Roche's application for Gazyva/Gazyvaro (obinutuzumab) as a treatment for primary membranous nephropathy (pMN). This autoimmune kidney condition can lead to severe kidney damage and failure. If approved, Gazyva would be the first FDA-sanctioned therapy for pMN, building on promising Phase III clinical trial results.