Roche has received approval from the European Commission (EC) for its humanised monoclonal antibody Gazyva/Gazyvaro (obinutuzumab) along with mycophenolate mofetil (MMF), for adults with active Class III or IV lupus nephritis, with or without concomitant Class V.
Lupus nephritis classifications indicate the severity and type of kidney damage, which is central to the disease.
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The EC’s decision is based on outcomes from the Phase II NOBILITY and Phase III REGENCY trials.
According to data from the REGENCY trial, 46.4% of participants treated with Gazyva/Gazyvaro alongside standard therapy (MMF and glucocorticoids) reached complete renal response, against 33.1% in those receiving only standard therapy.
Additional benefits included better disease control, reduced corticosteroid use, improvement in proteinuric response, lower anti-double-stranded DNA (dsDNA) and increased complement levels, all indicating reduced disease activity and inflammation.
Roche global product development head and chief medical officer Levi Garraway stated: “This approval marks a major advance in the treatment of lupus nephritis for people across Europe who wrestle with this disease.
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By GlobalData“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.”
Lupus nephritis mainly impacts women of colour and of childbearing age, with as many as 135,000 individuals living with the condition in the European Union (EU).
This approval follows the authorisation granted by the US Food and Drug Administration (FDA) in October 2025 for Gazyva/Gazyvaro to treat adults with active lupus nephritis who are undergoing standard therapy.
Gazyva/Gazyvaro is also being studied in adult systemic lupus erythematosus, childhood idiopathic nephrotic syndrome and other autoimmune or immune-related diseases, including ongoing trials in adults, children, and adolescents with related renal conditions.
