Genentech announced positive results from the Phase III study (REGENCY) of Gazyva (Obinutuzumab) for people with active lupus nephritis (LN). Gazyva is an engineered humanized monoclonal antibody designed to attack CD20, a protein found on certain types of B cells that cause inflammation and damage to the kidneys. Gazyva works to deplete disease-causing B cells to protect the kidney from further damage and potentially prevent or delay progression to end-stage renal disease.
The REGENCY study was a randomized, double-blind, placebo-controlled study that examined the efficacy and safety of Gazyva plus standard therapy of mycophenolate mofetil and glucocorticoids in 271 people with LN. The study met its primary endpoint and found a higher percentage of individuals receiving Gazyva along standard therapy achieved complete renal response at 76 weeks as evidenced by preserved estimated glomerular filtration rate (eGFR) and reduced kidney flare, compared to those who were treated with the placebo and standard therapy.
In addition to the REGENCY study, Gazyva is being studied in children and adolescents with LN, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus (SLE). Gazyva was granted Breakthrough Therapy designation by the FDA in 2019. Current data of Gazyva is being shared with health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency with the goal of making this treatment available soon. To learn more about this and other treatments on the horizon, watch this video.
Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.
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