Lupus Research Alliance Applauds U.S. FDA Approval of Gazyva® (Obinutuzumab) for Lupus Nephritis

Only Treatment Option to Target Underlying Cause of Serious Lupus Complication, Aiming to Preserve Kidney Function

NEW YORK, Oct. 20, 2025 /PRNewswire/ -- The Lupus Research Alliance applauds the approval by the U.S. Food and Drug Administration of Gazyva^® (obinutuzumab) from Genentech for the treatment of adults with active lupus nephritis in combination with standard of care. This is a major step forward for the entire lupus community, as it is the only anti-CD20 monoclonal antibody targeting an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease often resulting in dialysis or transplantation.

Lupus nephritis is inflammation of the kidney that occurs in patients with systemic lupus erythematosus. It is the most common serious complication of lupus, affecting about 50 percent of people with lupus and one of the most dangerous, as up to 30 percent of people advance to end-stage kidney disease.¹

"Given how many people living with lupus develop lupus nephritis and experience its severe complications, it is critical to have more treatment options available," Albert T. Roy, President & CEO of the Lupus Research Alliance, said. "As preserving kidney function is crucial for people with lupus, this U.S. FDA approval is an important milestone – bringing a new treatment with a positive safety and effectiveness profile. The Lupus Research Alliance has funded more than 80 foundational research projects in lupus nephritis that are paving the way for innovative treatment advances such as Gazyva."

Meeting Endpoints and Unmet Need
Gazyva is a type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on the surface of certain types of B cells. In lupus nephritis, disease-causing B cells drive inflammation. The benefits of the drug for lupus nephritis were shown in the Phase 2 NOBILITY and Phase 3 REGENCY clinical trials.

Several of the clinical trial study investigators are part of the Lupus Clinical Investigators Network (LuCIN), overseen by Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance. LuCIN and Lupus Therapeutics enable the development and acceleration of clinical trials for sponsors while supporting investigators, and ensuring individuals enrolled receive quality care.

"The U.S. FDA approval of obinutuzumab is an important new treatment option for people with lupus nephritis. Many people with this common and severe complication of lupus have inadequate responses to standard therapies," said Dr. Richard Furie, Chief of the Division of Rheumatology at Northwell, the study's lead investigator, and a member of LuCIN. "Obinutuzumab, the first anti-CD20 therapy currently approved for lupus nephritis, enhances B-cell depletion compared to previously studied anti-CD20 antibodies, providing complete renal response in nearly half of patients studied, without increasing the frequency of serious safety events. B cells play a critical role in lupus nephritis pathogenesis and currently are a popular target not only for lupus but other types of inflammatory diseases."

The Lupus Research Alliance is proud to be a long-standing partner with Genentech – working together to fund innovative research and connect with the lupus community. As part of that relationship, the Lupus Research Alliance and Lupus Therapeutics have worked with Genentech to ensure that the voices of those living with lupus are incorporated into the drug development process, supporting a series of patient advisory boards for the program.

"True progress in clinical research is only possible when those impacted are a part of the entire process," Stacie J. Bell, PhD, Chief Clinical Research Officer of Lupus Therapeutics. "With patients heard throughout the development of Gazyva, it is encouraging to see strong data in terms of slowing progression to end-stage kidney disease and addressing such an important unmet need – bringing hope to people living with this disease."

Additional information about the approval is available via Genentech's media release .

About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system, meant to defend against infections, produces autoantibodies that mistake the body's own cells as foreign, causing other immune cells to attack organs such as the kidneys, brain, heart, lungs and skin, as well as blood and joints. Ninety percent of people with lupus are women, most often diagnosed between the ages of 15-45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected by lupus.

About the Lupus Research Alliance
The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering scientific talent, and driving discovery toward better diagnostics, improved treatments and, ultimately, a cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.

For more information or to donate to lupus research, visit the LRA at LupusResearch.org and on social media at: X, Facebook, LinkedIn, and Instagram.

SOURCE Lupus Research Alliance