The LRA has applauded the U.S. Food and Drug Administration (FDA)’s approval of Gazyva® (obinutuzumab) for adults living with active lupus nephritis, a serious kidney complication of lupus. This marks a major milestone: Gazyva is the first anti-CD20 monoclonal antibody approved for this specific indication. Lupus Therapeutics+1

What’s Behind This Approval

• Lupus nephritis affects around half of people living with lupus and is among the most serious complications — up to 30 percent may progress to end-stage kidney disease (dialysis or transplant) without effective treatment. Lupus Therapeutics+1
• Clinical trials showed strong results: in the Phase 3 REGENCY trial, nearly 46.4 % of participants on Gazyva plus standard therapy achieved a “complete renal response” compared to ~33 % on standard therapy alone. Roche+1
• Importantly, Gazyva can be administered (after initial doses) twice yearly ,offering a potentially more convenient therapy option. Roche

Why This Matters for Our Community

For our Colorado lupus community, this approval brings renewed hope and opportunity:

• A new treatment path: Having an approved therapy that specifically targets the underlying immune process of lupus nephritis means more options for people seeking better outcomes.
• Potential for better kidney preservation: By helping more people achieve complete renal responses, Gazyva may slow or prevent long-term kidney damage—protecting organ function, reducing hospitalisations, and preserving quality of life.
• Recognition of the patient voice: People living with lupus were partners in the research process ,their lived experiences helped shape the trials. Lupus Therapeutics
• Momentum in lupus research: This approval reflects the broader progress in lupus care, brighter prospects, faster innovation, and improved collaboration between patients, researchers, and pharma.

What You Should Know

If you or a loved one are living with lupus nephritis or suspect kidney involvement, here are some next-steps:

• Talk with your rheumatologist or nephrologist about whether Gazyva might be appropriate — including eligibility, prior therapies used, and kidney status.
• Ask about insurance coverage and financial assistance programs, as new therapies can involve access challenges. Lupus Colorado can get you connected with patient assistance programs that will help cover the costs.
• Stay informed about ongoing research and clinical trials; even as new treatments become available, participation and shared decision-making remain vital.
• Connect with your community: sharing experiences, asking questions, and staying supported strengthen not only individual resilience but our collective voice.