On March 5, Roche announced that the U.S. FDA had accepted the company'sObinutuzumab (Obinutuzumab，Gazyva/Gazyvaro) For the treatment of lupus nephritisSupplemental Biologics License Application(sBLA)The FDA is expected to make an approval decision by October 2025. Obinutuzumab has previously been approved for the treatment of various lymphoma indications, and this submission concernsFirst Non-Oncology Indication Marketing Application。
Screenshot source: Roche official websiteLupus nephritis is a debilitating and potentially life-threatening disease. In lupus nephritis, pathogenic B cells trigger persistent inflammation, which damages the kidneys.Obinutuzumab is a targeted CD20 antibody that can help better control the disease by targeting pathogenic B cells, protect the kidneys from further damage, and may prevent or delay progression to end-stage renal disease.In 2019, based on data from the Phase II NOBILITY study, the FDA granted the drug Breakthrough Therapy designation for the treatment of lupus nephritis.This marketing application is based on the Phase III study REGENCY（NCT04221477）The positive results were announced in February 2025 at the World Congress of Nephrology. (WCN) Published simultaneously and featured in The New England Journal of Medicine.Data show that the REGENCY study met its primary endpoint;Nearly half of the patients who received obinutuzumab in combination with standard therapy achieved complete renal response, compared to those who received standard therapy alone. (CRR), with statistically significant and clinically meaningful improvement. In the study, patients receiving obinutuzumab in combination with standard therapy46.4% Achieved CRR at 76 Weeks, while the proportion was 33.1% among patients who received only standard treatment.In addition, the study also showed that patients' complement levels were clinically significantly improved, and markers of anti-dsDNA, disease activity, and inflammation were reduced. Pre-specified subgroup analyses demonstrated consistent CRR benefits across patient subgroups. The safety profile of obinutuzumab was consistent with its well-established characteristics observed in hematological indications.
Source: Insight DatabaseRoche pointed out in the press release,Obinutuzumab is the only anti-CD20 monoclonal antibody that has demonstrated a beneficial effect of CRR on lupus nephritis in randomized Phase III studies.The company also plans to submit a marketing application for obinutuzumab in this indication to the European EMA based on data from the Phase III REGENCY study.In addition to the REGENCY study, Roche is also evaluating obinutuzumab for the treatment of patients withChildren and adolescents with lupus nephritis, patients with membranous nephropathy, idiopathic nephrotic syndrome in childhoodAndSystemic Lupus ErythematosusEffectiveness and safety.In addition to Obinutuzumab, Roche's product pipeline in the field of immune-related kidney and associated diseases also includes:- Sefaxersen，A Targeted Complement Factor B（CFB）Antisense Oligonucleotide Therapy, is being developed for primary immunoglobulin A nephropathy(IgA Nephropathy)Phase III clinical trial for patients with high progression risk;
- Motalizumab（Mosunetuzumab）A CD20xCD3 T cell-engaging bispecific antibody is under investigation for systemic lupus erythematosus;
- Covalemonab（Crovalimab）A novel cyclic monoclonal antibody targeting C5 is currently in Phase III clinical trials for atypical hemolytic uremic syndrome.
- RG6382A CD19xCD3 T cell engaging bispecific antibody is currently in Phase I clinical trials for systemic lupus erythematosus;
- and P-CD19CD20-ALLO1, an allogeneic CD19 × CD20 dual-target CAR-T, is under development for systemic lupus erythematosus and multiple sclerosis indications.
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