Roche announced that the company’s supplemental biologics license application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis has been approved by the US Food and Drug Administration (FDA). Positive findings from the phase III REGENCY research, which demonstrated enhanced complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy in comparison to standard therapy alone, served as the basis for the filing acceptance. One By October 2025, the FDA is anticipated to reach a decision on approval.
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,
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.
Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
Lupus nephritis is a debilitating and potentially life-threatening condition that can lead to kidney failure and require dialysis or transplantation,
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.
Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America.
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About half of the patients on Gazyva/Gazyvaro plus standard therapy achieved a CRR, with a statistically significant and clinically meaningful improvement, compared with standard treatment alone, according to phase III REGENCY results that were concurrently presented at the World Congress of Nephrology (WCN) and published in the New England Journal of Medicine in February 2025. This was followed by decreases in anti-dsDNA, a hallmark of inflammation and disease activity, and clinically significant increases in complement levels. Consistent CRR benefit across patient subgroups was demonstrated by a pre-specified subgroup analysis, indicating therapy promise for a large patient population with a high unmet need. The safety profile of Gazyva/Gazyvaro aligned with the well-defined profile found in its indications for hematology and oncology.
Gazyva®/Gazyvaro® (obinutuzumab)
The Type II engineered humanized monoclonal antibody known as Gazyva®/Gazyvaro® (obinutuzumab) is made to bind to the protein CD20, which is present on specific B cell types. B cells that cause the disease are responsible for the chronic inflammation that harms the kidneys in lupus nephritis.
Source: Roche
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