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