Roche announced that the U.S. Food and Drug Administration (FDA) has approved Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. The FDA also approved a shorter 90-minute infusion time for eligible patients after the first dose.
Following an initial four doses in the first year, Gazyva can be administered twice yearly, providing an effective and potentially more convenient option compared to traditional targeted therapies.
Dr. Levi Garraway, Roche’s Chief Medical Officer, called the approval “an important step toward a new standard of care.” He said, “People with lupus nephritis who achieve a complete renal response are more likely to preserve kidney function and delay, or even prevent, progression to end-stage kidney disease.”
The decision was supported by results from the Phase II NOBILITY and Phase III REGENCY studies. In REGENCY, 46.4% of patients treated with Gazyva plus standard therapy achieved a complete renal response, compared with 33.1% for those on standard therapy alone. Patients also saw improvements in complement levels, reductions in anti-dsDNA antibodies and proteinuria, and lower corticosteroid use — all indicators of better disease control.
Louise Vetter, President and CEO of the Lupus Foundation of America, said the approval “offers renewed hope” to people living with lupus nephritis. “This is a severe, potentially life-threatening disease that greatly disrupts daily life. Gazyva provides an important new option that could help prevent long-term complications like kidney failure,” she said.
Lupus nephritis, an inflammation of the kidneys caused by lupus, affects over 1.7 million people worldwide, predominantly women of color and of childbearing age. Without effective treatment, up to a third of patients can progress to end-stage kidney disease requiring dialysis or transplant.
Gazyva was granted Breakthrough Therapy Designation in 2019, and a positive opinion from the European Medicines Agency is expected to lead to a European Commission decision soon.
Beyond lupus nephritis, Roche is exploring Gazyva in systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and pediatric lupus nephritis, underscoring the company’s commitment to advancing treatments for complex immune and kidney diseases.