The European Commission has approved Gazyva/Gazyvaro in combination with mycophenolate mofetil for treating adult patients with active lupus nephritis. This approval follows positive results from the phase II NOBILITY and phase III REGENCY studies, demonstrating Gazyva/Gazyvaro's superiority over standard therapy alone. The REGENCY study showed a higher rate of complete renal response in patients treated with Gazyva/Gazyvaro. The drug also led to a reduction in corticosteroid use and improvements in disease markers. Gazyva/Gazyvaro is the only anti-CD20 antibody to show a benefit in complete renal response in a randomized phase III lupus nephritis study. It has the potential to become a new standard of care for approximately 135,000 people in the EU affected by this condition. Lupus nephritis is a serious disease that can lead to end-stage kidney disease, requiring dialysis or transplant. This approval in the EU follows a similar approval in the United States. Gazyva/Gazyvaro is also being investigated for other autoimmune diseases. The drug is a monoclonal antibody targeting CD20, a protein on certain B cells.