FDA Expedites Review of Roche Drug for Rare Kidney Disease

The U.S. Food and Drug Administration (FDA) has given Priority Review status to Roche's application for Gazyva/Gazyvaro, a treatment for primary membranous nephropathy (pMN) in adults. This decision follows promising Phase III trial results, which indicated the drug's superior efficacy compared to an existing immunosuppressive therapy. Primary membranous nephropathy is a serious autoimmune condition that can cause irreversible kidney damage.