Roche Gazyva/Gazyvaro approved by European Commission for adults with active lupus nephritis

These disease classifications describe the extent and nature of damage to the kidneys and renal function, a key characteristic of lupus nephritis.

“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.

The approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies. Key results from REGENCY, 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. The safety profile of Gazyva/Gazyvaro was consistent with the well-characterised profile observed in its haematology-oncology indications.

“The symptoms of lupus nephritis and their unpredictable nature can impact quality of life, emotional wellbeing and limit future family and career prospects,” said Jeanette Andersen, Chair of Lupus Europe. “This approval for Gazyva/Gazyvaro offers a much needed treatment that may help ease the burden of living with this complex disease and reflects the vital role of patient community experts in trial development.”

Lupus nephritis is a potentially life-threatening disease that predominantly affects women of colour and childbearing age, with up to an estimated 135,000 people currently living with the condition across the European Union. With current treatments, up to one third of people will progress to end-stage kidney disease (ESKD) within 10 years, where the only options are dialysis or transplant. New treatments that can effectively control the disease may help delay or prevent the onset of ESKD

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.

Gazyva/Gazyvaro continues to be investigated in children and adolescents with lupus nephritis and adults with membranous nephropathy.