▎WuXiEdited by Kant Content Team

Recently, Genentech, a subsidiary of Roche, announced positive topline results from the Phase 3 clinical trial REGENCY, which evaluated the anti-CD20 antibody therapy Gazyva (obinutuzumab) for the treatment of lupus nephritis.Compared with patients who received only standard treatment, a higher proportion of patients who received Gazyva plus standard treatment achieved complete renal response (CRR) at 76 weeks.

Genentech is currently sharing these data with regulatory agencies, including the U.S. FDA and the European Medicines Agency (EMA), with the goal of making Gazyva a new treatment option for lupus nephritis as soon as possible. The data will also be submitted to medical journals for publication and presented at upcoming medical conferences.

In lupus nephritis, pathogenic B cells drive persistent inflammation, damaging the kidneys. Despite current treatment options, up to one-third of individuals will progress to end-stage renal disease within 10 years, with a high risk of mortality.Gazyva is an engineered humanized monoclonal antibody designed to bind to CD20 to deplete pathogenic B cells, which helps limit further damage to the kidneys and potentially prevent or delay the onset of end-stage renal disease.In 2019, based on the data from the Phase 2 clinical trial NOBILITY, it was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of lupus nephritis.

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