European Commission approves Roche’s Gazyva/Gazyvaro for adults with active lupus nephritis
17 Dec 2025
Gazyva®/Gazyvaro® (obinutuzumab)
Roche has announced that the European Commission has approved Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis.
These disease classifications describe the extent and nature of damage to the kidneys and renal function, a key characteristic of lupus nephritis.
The approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies. Key results from REGENCY1, published in the New England Journal of Medicine, demonstrated that 46.4% of people on Gazyva/Gazyvaro plus standard therapy (MMF and glucocorticoids) achieved a complete renal response compared to 33.1% on standard therapy alone.
Data showed a statistically significant and clinically meaningful reduction of corticosteroid use and an improvement in proteinuric response, all signalling improved disease control. Additionally, clinically meaningful improvements in complement levels and reductions in anti-dsDNA were observed, both markers of disease activity and inflammation.
This approval follows the Gazyva/Gazyvaro approval by the US Food and Drug Administration for the treatment of adults with active lupus nephritis who are receiving standard therapy in October 2025.
Additionally, recent positive phase III read-outs in childhood idiopathic nephrotic syndrome and adult systemic lupus erythematous support the potential of Gazyva/Gazyvaro to help address disease activity across a spectrum of autoimmune or immune-related diseases.
“This approval marks a major advance in the treatment of lupus nephritis for people across Europe who wrestle with this disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By controlling disease activity, Gazyva/Gazyvaro could help delay or prevent progression to end-stage kidney disease and the need for dialysis or transplant, underscoring its potential to become a new standard of care in Europe.”
Gazyva/Gazyvaro continues to be investigated in children and adolescents with lupus nephritis and adults with membranous nephropathy.
References
1. Richard A. Furie, M.D., Brad H. Rovin, M.D., et al. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. February 7, 2025. N Engl J Med 2025;392:1471-1483. DOI: 10.1056/NEJMoa2410965