The US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application for Roche’s brand of obinutuzumab (Gazyva®/Gazyvaro®) for the treatment of lupus nephritis.
"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, 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."
In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys.
Obinutuzumab, a humanized monoclonal antibody, works by targeting and attaching to CD20, a protein found on these cells, easing the inflammatory process and helping gain better control of the disease.
The application acceptance by the FDA is based on data from a phase III clinical trial coded REGENCY that demonstrated improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared with standard therapy alone.
Additionally, the study, now published in the New England Journal of Medicine, showed that there were clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity, and inflammation.
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To this date, Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomized phase III study to demonstrate a CRR benefit in lupus nephritis.
"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, Ph.D., Head of Global Product Development, Roche. "The FDA's sBLA acceptance for Gazyva/Gazyvaro recognizes the need to provide a more effective treatment option for people living with this devastating disease."
It is anticipated that the FDA will make a decision by October 2025.
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APR Team
African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.
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