Roche's Gazyva/Gazyvaro Lands Priority Review From US FDA in Nephropathy

01:39 AM EDT, 07/15/2026 (MT Newswires) -- Roche's (RO.SW) supplemental biologics license application for Gazyva/Gazyvaro received priority review from the US Food and Drug Administration for the treatment of primary membranous nephropathy, or pMN, a chronic autoimmune disease with no approved therapies in the US or Europe. The priority review is based on the pharmaceutical company's phase 3 Majesty results, in which 36.9% of adults achieved complete remission after two years, compared with 5.7% of patients treated with the immunosuppressive therapy tacrolimus, according to a Wednesday release. The FDA, which previously granted breakthrough therapy designation to Gazyva/Gazyvaro in pMN, is expected to decide on the application by November. Roche is also submitting the trial data to the European Medicines Agency and other global health authorities. Gazyva/Gazyvaro is already cleared in the US and European Union for adults with active lupus nephritis and is under investigation for the treatment of children and adolescents with the disease.