FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
Roche (RHHBY) announced FDA acceptance of supplemental Biologics License Application for Gazyva/Gazyvaro to treat lupus nephritis, with approval decision expected by October 2025. The application is based on successful phase III REGENCY study results, where the drug demonstrated superior complete renal response when combined with standard therapy.
Nearly half of patients receiving Gazyva/Gazyvaro plus standard therapy achieved complete renal response, showing statistically significant improvement versus standard treatment alone. The drug's safety profile aligned with previous findings in hematology-oncology applications.
Lupus nephritis affects 1.7 million people globally, with up to one-third of patients on current treatments progressing to end-stage kidney disease within 10 years. Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomized phase III study showing complete renal response benefit in lupus nephritis.
Roche (RHHBY) ha annunciato l'accettazione da parte della FDA della domanda supplementare per la Licenza Biologica per Gazyva/Gazyvaro per il trattamento della nefrite lupica, con una decisione di approvazione attesa entro ottobre 2025. La domanda si basa sui risultati positivi dello studio REGENCY di fase III, dove il farmaco ha dimostrato una risposta renale completa superiore quando combinato con la terapia standard.
Quasi la metà dei pazienti che ricevevano Gazyva/Gazyvaro insieme alla terapia standard ha raggiunto una risposta renale completa, mostrando un miglioramento statisticamente significativo rispetto al solo trattamento standard. Il profilo di sicurezza del farmaco è risultato in linea con le scoperte precedenti nelle applicazioni di ematologia-oncologia.
La nefrite lupica colpisce 1,7 milioni di persone a livello globale, con fino a un terzo dei pazienti in trattamento attuale che progrediscono verso la malattia renale allo stadio finale entro 10 anni. Gazyva/Gazyvaro è l'unico anticorpo monoclonale anti-CD20 in uno studio randomizzato di fase III che mostra un beneficio in termini di risposta renale completa nella nefrite lupica.
Roche (RHHBY) anunció la aceptación por parte de la FDA de la solicitud suplementaria de Licencia Biológica para Gazyva/Gazyvaro para tratar la nefritis lúpica, con una decisión de aprobación esperada para octubre de 2025. La solicitud se basa en los resultados exitosos del estudio REGENCY de fase III, donde el fármaco demostró una respuesta renal completa superior cuando se combinó con la terapia estándar.
Casi la mitad de los pacientes que recibieron Gazyva/Gazyvaro junto con la terapia estándar lograron una respuesta renal completa, mostrando una mejora estadísticamente significativa en comparación con el tratamiento estándar solo. El perfil de seguridad del fármaco se alineó con hallazgos anteriores en aplicaciones de hematología-oncología.
La nefritis lúpica afecta a 1,7 millones de personas en todo el mundo, con hasta un tercio de los pacientes en tratamientos actuales que progresan a enfermedad renal en etapa terminal dentro de 10 años. Gazyva/Gazyvaro es el único anticuerpo monoclonal anti-CD20 en un estudio aleatorizado de fase III que muestra un beneficio en la respuesta renal completa en la nefritis lúpica.
로슈 (RHHBY)는 가지바/Gazyvaro의 루푸스 신염 치료를 위한 보충 생물학적 제품 허가 신청이 FDA에 의해 수용되었다고 발표했으며, 승인 결정은 2025년 10월에 예상됩니다. 이 신청은 3상 REGENCY 연구의 성공적인 결과를 기반으로 하며, 약물이 표준 요법과 결합했을 때 우수한 완전 신장 반응을 나타냈습니다.
가지바/Gazyvaro와 표준 요법을 함께 받은 환자의 거의 절반이 완전 신장 반응을 달성했으며, 이는 단독 표준 치료에 비해 통계적으로 유의미한 개선을 보여주었습니다. 약물의 안전성 프로필은 혈액학-종양학 응용 프로그램에서의 이전 발견과 일치했습니다.
루푸스 신염은 전 세계적으로 170만 명에게 영향을 미치며, 현재 치료를 받고 있는 환자의 최대 3분의 1이 10년 이내에 말기 신장 질환으로 진행됩니다. 가지바/Gazyvaro는 루푸스 신염에서 완전 신장 반응 이점을 보여주는 3상 무작위 연구에서 유일한 항-CD20 단클론 항체입니다.
Roche (RHHBY) a annoncé l'acceptation par la FDA d'une demande de licence biologique supplémentaire pour Gazyva/Gazyvaro pour traiter la néphrite lupique, avec une décision d'approbation attendue d'ici octobre 2025. La demande est basée sur les résultats réussis de l'étude REGENCY de phase III, où le médicament a montré une réponse rénale complète supérieure lorsqu'il est associé à une thérapie standard.
Près de la moitié des patients recevant Gazyva/Gazyvaro en plus de la thérapie standard ont atteint une réponse rénale complète, montrant une amélioration statistiquement significative par rapport au traitement standard seul. Le profil de sécurité du médicament était en accord avec les résultats précédents dans les applications d'hématologie-oncologie.
La néphrite lupique touche 1,7 million de personnes dans le monde, avec jusqu'à un tiers des patients sous traitements actuels progressant vers une maladie rénale terminale dans les 10 ans. Gazyva/Gazyvaro est le seul anticorps monoclonal anti-CD20 dans une étude randomisée de phase III montrant un bénéfice en termes de réponse rénale complète dans la néphrite lupique.
Roche (RHHBY) hat die Annahme des FDA-Antrags auf eine ergänzende Biologics-Lizenzanwendung für Gazyva/Gazyvaro zur Behandlung von Lupusnephritis bekannt gegeben, wobei eine Genehmigungsentscheidung bis Oktober 2025 erwartet wird. Der Antrag basiert auf erfolgreichen Ergebnissen der Phase-III-REGENCY-Studie, in der das Medikament eine überlegene vollständige renale Antwort in Kombination mit der Standardtherapie zeigte.
Fast die Hälfte der Patienten, die Gazyva/Gazyvaro zusammen mit der Standardtherapie erhielten, erzielte eine vollständige renale Antwort und zeigte eine statistisch signifikante Verbesserung im Vergleich zur alleinigen Standardbehandlung. Das Sicherheitsprofil des Medikaments stimmte mit früheren Ergebnissen in der Hämatologie-Onkologie überein.
Lupusnephritis betrifft weltweit 1,7 Millionen Menschen, wobei bis zu ein Drittel der Patienten unter aktuellen Behandlungen innerhalb von 10 Jahren in die Endstadium-Nierenkrankheit übergeht. Gazyva/Gazyvaro ist der einzige anti-CD20-Monoklonalantikörper in einer randomisierten Phase-III-Studie, der einen Nutzen hinsichtlich der vollständigen renalen Antwort bei Lupusnephritis zeigt.
- FDA acceptance of sBLA for lupus nephritis treatment
- Nearly 50% of patients achieved complete renal response in Phase III trial
- Consistent efficacy across patient subgroups
- Breakthrough Therapy Designation previously granted by FDA
- Final FDA approval still pending
- Safety concerns consistent with existing hematology-oncology profile
- Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit1
- The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis1
- Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years2-5
Basel, 5 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared with standard therapy alone.1 The FDA is expected to make a decision on approval by October 2025.
“In people with lupus nephritis, Gazyva/Gazyvaro demonstrated a complete renal response benefit, a meaningful clinical outcome linked to preservation of kidney function, and slowing or prevention of end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The FDA’s sBLA acceptance for Gazyva/Gazyvaro recognises the need to provide a more effective treatment option for people living with this devastating disease.”
“Lupus nephritis is a debilitating and potentially life-threatening condition that can lead to kidney failure and require dialysis or transplantation,” said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. “Given the relatively young age of onset, people with lupus nephritis experience more years of disease-related complications and decreased quality of life due to the significant burden of this illness. We are hopeful for a new treatment option that can effectively reduce these risks and improve the health of all people affected by this disease.”
The phase III REGENCY results, which were simultaneously presented at the World Congress of Nephrology (WCN) and published in the New England Journal of Medicine in February 2025, showed that nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a CRR, with a statistically significant and clinically meaningful improvement, compared with standard treatment alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation. A pre-specified subgroup analysis showed consistent CRR benefit across patient subgroups, highlighting treatment potential for a broad patient population with a high unmet need. Gazyva/Gazyvaro’s safety profile was consistent with the well-characterised profile observed in its haematology-oncology indications.
Data from the phase III REGENCY study are also being used for a filing submission with the European Medicines Agency.
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus nephritis.1 In 2019, Gazyva/Gazyvaro was granted Breakthrough Therapy Designation by the FDA based on data from the phase II NOBILITY study. In addition to REGENCY, Gazyva/Gazyvaro is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis.6-9
Our pipeline in immunological kidney and related diseases also includes Sefaxersen (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, PiaSky® (crovalimab), a novel recycling monoclonal antibody being investigated in atypical haemolytic uraemic syndrome, RG6382, a CD19xCD3 T-cell engaging bispecific antibody being investigated in SLE, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T.
About Gazyva/Gazyvaro in kidney diseases
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.10 In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.11 We can target disease-causing B cells, an underlying cause of lupus nephritis, with Gazyva/Gazyvaro to help gain better control of the disease, protect the kidneys from further damage and potentially prevent or delay progression to end-stage kidney disease.
Gazyva/Gazyvaro is already approved in 100 countries for various types of lymphoma. In the United States, Gazyva 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 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.
The REGENCY study met its primary endpoint; nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone. In the study,
About lupus nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.2 Lupus nephritis affects approximately 1.7 million people worldwide. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.3,4 Lupus nephritis has a profound impact on the lives and outlook of those affected. Even with the latest treatments, the damage caused to the kidneys usually gets worse over time, with up to a third of people progressing to end-stage kidney disease within 10 years, where the only options are dialysis or transplant, and the risk of mortality is high.5 Lupus nephritis predominantly affects women, mostly women of colour and usually of childbearing age.12 Currently, there is no cure.5
About Roche in kidney diseases
For 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Our industry-leading pipeline includes several ongoing phase I-III clinical studies of immune-mediated investigational therapies, with the aim of bringing innovative new treatment options to people living with kidney and kidney-related diseases, including lupus nephritis, membranous nephropathy, immunoglobulin A nephropathy, atypical haemolytic uraemic syndrome, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus, an autoimmune disease that can lead to lupus nephritis.
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
[1] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. NEJM. [Internet; cited March 2025]. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2410965.
[2] Hocaoglu M et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades—The Lupus Midwest Network (LUMEN). Arthritis Rheumatol. 202;75(4):567–73.
[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023;82:351-56.
[4] Hoi A, et al. Systemic lupus erythematosus. The Lancet. 2024;403(10441):2326-38.
[5] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023;19:227-38.
[6] 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 March 2025]. Available from: https://clinicaltrials.gov/study/NCT05039619.
[7] Clinicaltrials.gov. A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited March 2025]. Available from: https://clinicaltrials.gov/study/NCT04629248.
[8] 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 March 2025]. Available from: https://clinicaltrials.gov/study/NCT05627557.
[9] Clinicaltrials.gov. A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited March 2025]. Available from: https://clinicaltrials.gov/study/NCT04963296.
[10] 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;12(10):2031-42.
[11] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Invest. 2021;131(12):e149095.
[12] Anders HJ, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7. doi: 10.1038/s41572-019-0141-9.
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FAQ
What are the key findings from Roche's REGENCY trial for Gazyva/Gazyvaro (RHHBY) in lupus nephritis?
When is the FDA expected to make a decision on Roche's Gazyva/Gazyvaro (RHHBY) for lupus nephritis?
How many people are affected by lupus nephritis globally according to Roche's data?
What distinguishes Gazyva/Gazyvaro from other treatments for lupus nephritis (RHHBY)?
