Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat lupus nephritis. 

The filing acceptance is based on results from the phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared to standard therapy. The FDA is expected to decide on approval by October 2025.

The phase III REGENCY study showed that nearly half of the patients on Gazyva/Gazyvaro plus standard therapy achieved a CRR, with improvement, compared with standard treatment alone. This was accompanied by improvements in complement levels and reductions in anti-dsDNA, markers of disease activity, and inflammation.

A pre-specified subgroup analysis showed CRR benefits across patient subgroups. Gazyva/Gazyvaro’s safety profile was consistent with the profile observed in its hematology-oncology indications.

“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 recognizes the need to provide a more effective treatment option for people living with this devastating disease.”

In 2019, Gazyva/Gazyvaro was granted Breakthrough Therapy Designation by the FDA based on data from the Phase II NOBILITY study. Besides REGENCY, Gazyva/Gazyvaro is also 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.

Data from the Phase III REGENCY study are also being used for a filing submission with the European Medicines Agency.

REGENCY study results were presented at the World Congress of Nephrology (WCN) and published in the New England Journal of Medicine in February 2025.