FDA Approves New Treatment for Lupus Nephritis
Roche has received U.S. Food and Drug Administration (FDA) approval for its medicine Gazyva (obinutuzumab) to treat adults with active lupus nephritis who are already on standard therapy. The drug, long used in hematologic cancers, will now enter the lupus treatment space following positive results from late-stage clinical studies.
Roche’s Genentech division announced that Gazyva will be administered as four infusions in the first year, followed by twice-yearly maintenance doses. A shorter 90-minute infusion option will be available for eligible patients after the initial treatment. Lupus nephritis, a serious complication of systemic lupus erythematosus (SLE), can lead to irreversible kidney damage, with up to one-third of patients progressing to end-stage kidney disease even under existing therapies.
Mechanism of Action and Clinical Trials
Gazyva is a monoclonal antibody that targets CD20, a protein on certain B cells. By depleting disease-causing B cells, Roche aims to reduce inflammation and slow kidney deterioration in lupus nephritis patients. The FDA’s decision was supported by data from Roche’s phase II NOBILITY and phase III REGENCY trials, which evaluated the drug’s safety and efficacy.
In the REGENCY study, 46.4% of participants who received Gazyva plus standard therapy achieved a complete renal response, compared with 33.1% of those on standard treatment alone. The company also reported improvements in complement levels, reduced anti-double-stranded DNA antibodies, lower corticosteroid use, and decreased proteinuria—indicators of enhanced disease control. However, the treatment did not show significant advantages in certain secondary endpoints, such as estimated glomerular filtration rate (eGFR) and renal-related outcomes.
A New Standard of Care
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, said, “People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease.” He added that the approval could represent an important advancement toward a new standard of care for the condition.
Louise Vetter, President and Chief Executive Officer of the Lupus Foundation of America, noted that the new approval provides hope for patients and families dealing with lupus nephritis, a condition that often leads to chronic pain, fatigue, and anxiety over declining kidney health.
Market Impact and Future Development
Gazyva was initially approved in 2013 for chronic lymphocytic leukemia and later gained approvals for additional blood cancer indications, including follicular lymphoma. The lupus nephritis authorization marks its fifth overall indication. In 2024, Gazyva generated 910 million Swiss francs (approximately $1.15 billion) in sales for Roche, reflecting a 16% year-over-year increase. Analysts at GlobalData have projected that sales could rise to $1.7 billion by 2030 with the new approval.
More than 1.7 million people worldwide are affected by lupus nephritis, according to Roche, with women, particularly women of color and those of childbearing age, most commonly impacted. For patients who progress to advanced disease, dialysis or kidney transplantation often becomes necessary.
The FDA approval closely follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which recommended Gazyva, alongside mycophenolate mofetil, for the treatment of lupus nephritis. A final decision from the European Commission is pending.
In the United States, Gazyva is developed under a partnership between Genentech and Biogen. Roche continues to study the therapy for additional autoimmune and kidney-related conditions, including systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and pediatric lupus nephritis.
