EU Approves Roche’s Gazyva for Advanced Lupus Nephritis Treatment
Roche announced that the European Commission has granted approval for Gazyva®/Gazyvaro® (obinutuzumab) combined with mycophenolate mofetil (MMF) to treat adults with active Class III or IV lupus nephritis, with or without Class V involvement. This decision marks a significant regulatory milestone for patients across Europe living with this severe and potentially life-threatening autoimmune kidney disease.
Lupus nephritis, a complication of systemic lupus erythematosus (SLE), is characterized by inflammation and structural damage in the kidneys. The condition disproportionately affects women of colour and those of childbearing age, with an estimated 135,000 people impacted across the European Union. Disease severity is classified into several categories, with Class III and IV representing the most aggressive forms. Without effective treatment, up to one third of patients progress to end-stage kidney disease (ESKD) within a decade, requiring dialysis or kidney transplantation.
Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, described the approval as a major therapeutic advance. “By controlling disease activity, Gazyva/Gazyvaro could help delay or prevent progression to end-stage kidney disease,” he said. “This underscores its potential to become a new standard of care in Europe.”
The approval is supported by results from two key clinical studies: the Phase II NOBILITY trial and the Phase III REGENCY trial. Findings from REGENCY, published in the New England Journal of Medicine, demonstrated compelling clinical benefits. In the study, 46.4% of patients receiving Gazyva/Gazyvaro alongside MMF and glucocorticoids achieved a complete renal response, compared with 33.1% among those who received standard therapy alone. These results showed a statistically significant improvement in kidney function outcomes and overall disease control.
Additional REGENCY data highlighted reductions in corticosteroid exposure—an important advancement given the long-term side effects associated with steroid use. Participants also showed improved proteinuric responses and favorable changes in biomarkers such as complement levels and anti-dsDNA antibodies, both of which are closely linked to disease activity. Importantly, the safety profile of Gazyva/Gazyvaro was consistent with its established use in hematology-oncology, with no new safety concerns identified.
Jeanette Andersen, Chair of Lupus Europe, emphasized the importance of new therapeutic options for the community. “The symptoms of lupus nephritis and their unpredictability can limit quality of life, emotional wellbeing, and future prospects,” she said. “This approval offers a much-needed treatment that may ease the burden of this complex disease.”
The European approval follows similar authorization by the U.S. Food and Drug Administration in October 2025 for adults with active lupus nephritis receiving standard therapy. Roche continues to expand research on Gazyva/Gazyvaro across a range of immune-mediated diseases, including ongoing investigations in pediatric lupus nephritis, adult membranous nephropathy, childhood idiopathic nephrotic syndrome, and systemic lupus erythematosus.
With mounting clinical evidence and expanding regulatory endorsements, Gazyva/Gazyvaro is poised to play an increasingly central role in the therapeutic landscape of autoimmune kidney disease—offering new hope for patients at high risk of kidney failure.