FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
- FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2
- Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study2
- Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease3-6