FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis

FDA approval of Gazyva expands therapeutic options for lupus care

WASHINGTON, Oct. 20, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus nephritis (LN), also known as lupus-related kidney disease. Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by targeting and eliminating certain B cells, which are believed to promote inflammation which causes kidney damage in LN. LN occurs in up to 60% of people with lupus and can lead to permanent kidney damage and even kidney failure if not effectively treated.

"Every new treatment that improves outcomes for people living with lupus nephritis is a tremendous victory," said Louise Vetter, President & CEO, Lupus Foundation of America. "The FDA's approval of Gazyva to treat lupus nephritis is an exciting milestone that illustrates medical advances in treatment options for those living with this debilitating, chronic condition."

The approval is based on positive results of the Phase II NOBILITY and Phase III REGENCY trials. In the REGENCY trial, nearly half (46.4%) of those treated with Gazyva in addition to standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response, meaning their kidney function returned to normal with little to no protein in the urine, compared to individuals who received standard therapy alone. This represents a statistically significant and clinically meaningful improvement in kidney outcomes for people affected by lupus nephritis, because restoring normal kidney function and reducing protein in the urine can prevent long-term kidney damage and reduce the risk of kidney failure.

Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomized Phase III study. For eligible patients living with lupus nephritis, Gazyva can be administered twice yearly following four initial doses in the first year.

"There has been significant progress in lupus treatment over the last several years, specifically for lupus nephritis. Today's FDA approval of Gazyva provides another important option to help manage and mitigate one of the most severe complications of lupus," shared Susan Manzi, MD, MPH, Lupus Foundation of America Board member, and Medical Director and Chair, Allegheny Health Network Medicine Institute and Director, Lupus Center of Excellence. "This new treatment option wouldn't be possible without the people living with lupus who recognized the importance of their participation in clinical trials, a necessary step in drug development."

People living with LN are at risk of experiencing serious kidney complications, like kidney failure, and may require dialysis, a machine that cleans the blood, or a kidney transplant. While recent years have brought important progress in the development of lupus nephritis treatments, with therapies such as belimumab and voclosporin, many living with lupus still do not achieve complete remission of their disease. The approval of Gazyva provides another option, though experts stress the continued need for additional innovation as only 4 out of 10 people living with LN, on average, respond to these therapies and a significant proportion experience cycles of disease flares and remission.

The Lupus Foundation of America has played a pivotal role in advancing this new treatment for people living with LN by educating the lupus community and connecting them with information about clinical trials of Gazyva through our Center for Clinical Trials Education program, while also raising awareness of the urgent need for new treatment options, and advocating before Congress to expand research and improve access to quality care and life-saving medications.

About the Lupus Foundation of America 

The Lupus Foundation of America is the premier patient advocacy organization devoted to solving the mystery of lupus, a devastating autoimmune condition where the immune system attacks organs throughout the body, while giving caring support to those who suffer from its brutal impact. Through a comprehensive program of research, education, and advocacy, we lead the fight to improve the quality of life for all people affected by lupus. Learn more about the Lupus Foundation of America at lupus.org.

Contact:
Mike Donnelly
[email protected]
(202) 349-1162

SOURCE Lupus Foundation of America, Inc.