Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Wednesday that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Gazyva (obinutuzumab) as a treatment for lupus nephritis. The filing is based on positive data from the Phase III REGENCY study, which showed Gazyva combined with standard therapy significantly improved complete renal response (CRR) compared to standard therapy alone. The FDA is expected to make a decision by October 2025.

The REGENCY study, presented at the World Congress of Nephrology in February 2025, demonstrated that nearly half of the patients on Gazyva plus standard therapy achieved a CRR, with improvements in complement levels and reductions in anti-dsDNA, markers of disease activity. Gazyva's safety profile in this study aligned with its known profile in hematology-oncology. A filing with the European Medicines Agency is also underway using this data.

Lupus nephritis affects 1.7 million people globally, with up to a third of those on current treatments progressing to end-stage kidney disease within 10 years. Gazyva is the only anti-CD20 monoclonal antibody to demonstrate CRR benefit in lupus nephritis in a randomised Phase III study.

Genentech's broader pipeline includes several therapies under investigation for kidney diseases, including lupus nephritis, with the goal of addressing significant unmet needs in immunological kidney disorders.