Roche Secures European Commission Approval For Gazyva/Gazyvaro In Active Class III Or IV Lupus Nephritis, With Or Without Class V

Benzinga·12/09/2025 07:02:18

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Approval based on phase II NOBILITY and phase III REGENCY studies showing superiority of Gazyva/Gazyvaro over standard therapy alone
Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a benefit in a complete renal response in lupus nephritis in a randomised phase III study
Gazyva/Gazyvaro could become a new standard of care for up to an estimated 135,000 people affected by lupus nephritis in the European Union, potentially helping to delay or prevent end-stage kidney disease