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FDA Accepts Supplemental Biologics License Application for Gayzva for Treatment of Lupus Nephritis
Today, the U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for Gazyva® (Obinutuzumab), for the potential treatment of lupus nephritis, (LN, lupus-related kidney disease). A sBLA is a request submitted to the FDA to approve changes to an already licensed biologic product - in this case, a new indication.
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 when a person’s kidneys stop functioning, requiring dialysis or kidney transplant. According to Phase III REGENCY clinical trial results published earlier this month, nearly half (46.4%) of the people in the study who received Gazyva plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response, demonstrating a statistically significant and clinically meaningful improvement compared to those who received standard treatment alone.
In addition to the REGENCY clinical trial, Gazyva is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis.
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.