Roche Receives FDA Approval for Gazyva/Gazyvaro in Treating Lupus Nephritis, Marking a Milestone in Autoimmune Kidney Disease Care

Roche Receives FDA Approval for Gazyva/Gazyvaro in Treating Lupus Nephritis, Marking a Milestone in Autoimmune Kidney Disease Care

(IN BRIEF) Roche has received FDA approval for Gazyva/Gazyvaro (obinutuzumab) as a treatment for adult patients with active lupus nephritis, supported by data from the NOBILITY and REGENCY trials that showed significantly improved renal response compared with standard therapy. The treatment can be administered twice yearly after an initial series of infusions and includes a shorter 90-minute infusion time for eligible patients. Lupus nephritis, which affects over 1.7 million people globally, disproportionately impacts women of colour and is a major cause of kidney failure. This approval positions Gazyva/Gazyvaro as a potential new standard of care and a major advance in autoimmune kidney disease management.

(PRESS RELEASE) BASEL, 20-Oct-2025 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that the U.S. Food and Drug Administration (FDA) has approved Gazyva®/Gazyvaro® (obinutuzumab) for adult patients with active lupus nephritis (LN) who are already receiving standard therapy. The approval also includes a shorter, 90-minute infusion time after the first dose for eligible patients, enhancing both treatment effectiveness and patient convenience. Following an initial four-dose regimen during the first year, the therapy can be continued with just two infusions annually, presenting a more manageable long-term approach for patients.

This FDA decision was supported by data from the phase II NOBILITY and phase III REGENCY trials, which demonstrated Gazyva/Gazyvaro’s superior efficacy over standard therapy alone. In the REGENCY study, nearly half of participants (46.4%) achieved a complete renal response (CRR) when treated with Gazyva/Gazyvaro plus standard therapy, compared with 33.1% of those receiving standard treatment alone. Patients also showed significant improvements in complement levels, reduced anti-dsDNA antibodies, lower corticosteroid use, and decreased proteinuria, all indicating improved kidney function and disease control.

“Achieving a complete renal response is a crucial milestone for people living with lupus nephritis, as it helps preserve kidney function and can delay or prevent progression to end-stage kidney disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This approval establishes Gazyva/Gazyvaro as an important new treatment option that may redefine the standard of care for this serious autoimmune condition.”

Louise Vetter, President and CEO of the Lupus Foundation of America, also welcomed the news, emphasizing that the approval represents renewed hope for patients living with the challenges of lupus nephritis. “This disease can severely disrupt daily life, bringing chronic pain, fatigue, and constant uncertainty about kidney health,” she said. “Gazyva/Gazyvaro offers a new therapeutic path that can help prevent long-term complications, including kidney failure.”

Lupus nephritis, a severe inflammation of the kidneys caused by systemic lupus erythematosus (SLE), affects more than 1.7 million people worldwide—predominantly women of colour and of childbearing age. Without effective treatment, up to one-third of patients progress to end-stage kidney disease requiring dialysis or transplant.

Gazyva/Gazyvaro, the first anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in a randomized phase III lupus nephritis trial, received Breakthrough Therapy Designation from the FDA in 2019. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has also issued a positive recommendation for its approval in the European Union, with a final decision expected soon. Roche continues to explore obinutuzumab’s potential in treating other immune-mediated and kidney-related conditions, including systemic lupus erythematosus, membranous nephropathy, and idiopathic nephrotic syndrome.

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.¹² In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly.¹³ Data suggests that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.²

Gazyva/Gazyvaro is already approved in 100 countries for various types of haematological cancers. In the United States, Gazyva/Gazyvaro is part of a collaboration between Genentech and Biogen.

About the REGENCY study
REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis.

About lupus nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.⁷ Lupus nephritis is characterised by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and, if left unchecked, may lead to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.⁵

Lupus nephritis affects more than 1.7 million people worldwide – predominantly women, mostly of colour and usually of childbearing age.⁶ Currently, there is no cure.⁷

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
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[2] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.
[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Annals of the Rheumatic Diseases. 2023 Mar;82:351-56.
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[7] Hocaoglu M et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 A.pr;75(4):567-5.
[8] Clinicaltrials.gov. A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT04963296.
[9] Clinicaltrials.gov. A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT04629248.
[10] Clinical trials.gov. A study to evaluate the efficacy and safety of obinutuzumab versus MMF in participants with childhood onset idiopathic nephrotic syndrome (INShore). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05627557.
[11] Clinicaltrials.gov. A study to evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescents with active class III or IV lupus nephritis and the safety and PK of obinutuzumab in pediatric participants (POSTERITY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05039619.
[12] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[13] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Investig. 2021 Jun 15;131(12):e149095.

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SOURCE: Roche