FDA Approves Roche’s Gazyva for Lupus Nephritis with Streamlined Dosing

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 approval also includes a new, faster 90-minute infusion option after the first dose for eligible patients.

The treatment, previously approved for blood cancers, can now be administered as four initial doses in the first year, followed by maintenance doses twice a year. This regimen offers a more convenient and potentially more effective option compared to traditional therapies.

“Achieving complete renal response in lupus nephritis is key to preserving kidney function and delaying or preventing progression to end-stage kidney disease,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “This approval marks an important step toward a new standard of care.”

Louise Vetter, CEO of the Lupus Foundation of America, highlighted the significance of the decision: “This approval offers renewed hope for people living with lupus nephritis. It could help prevent long-term complications like kidney failure and improve quality of life.”

The FDA decision is based on data from the phase II NOBILITY and phase III REGENCY trials. In REGENCY, 46.4% of patients on Gazyva in combination with standard therapy achieved a complete renal response, compared to 33.1% on standard therapy alone. Additional improvements were seen in key biomarkers and reductions in steroid use and proteinuria. The safety profile was consistent with previous indications.

Lupus nephritis affects over 1.7 million people globally and is especially prevalent among women of color and women of childbearing age. Without effective treatment, the disease can lead to end-stage kidney disease requiring dialysis or transplantation.

Gazyva was granted Breakthrough Therapy Designation by the FDA in 2019. A decision on its approval in Europe is expected soon, following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Beyond lupus nephritis, Roche is also investigating Gazyva in several related conditions, including systemic lupus erythematosus and pediatric lupus nephritis, as part of its broader immunology pipeline.