FDA Grants Breakthrough Status for First-Ever Treatment for Lupus Nephritis Called Gazvya

The U.S. Food and Drug Administration granted breakthrough therapy designation of obinutuzumab (Gazyva) for lupus nephritis, major morbidity of systemic lupus erythematosus (SLE). Gazyva is a treatment for chronic lymphocytic leukemia. A monoclonal antibody, it blocks CD20, a protein found on the surface of B lymphocytes where chronic lymphocytic leukemia cells reside. FDA breakthrough status was based on the phase II NOBILITY study.

Challenge: Finding an Effective Lupus Nephritis Treatment

The pursuit of treatment for lupus nephritis has been a big challenge. To date, most treatments involve a high risk of adverse events while producing limited success. Rheumatology Network reports that a primary objective has been to design a treatment that can suppress autoimmune pathways that nurture inflammation. One avenue of research has been B-cells—long thought to offer an avenue of attack against overactive autoimmune pathways. But it has been an incredibly difficult path of research—with the exception of GSK’s belimumab (Benlysta) which was approved for systemic lupus, not much else has worked.

The Breakthrough Status

The FDA granted breakthrough status on obinutuzumab for lupus nephritis based on the results of Phase II randomized, double-blind NOBILITY clinical trial which revealed that obinutuzumab combined with mycophenolate mofetil or mycophenolic acid and corticosteroids led to more cases of a complete renal response in advanced lupus nephritis cases as compared to the group receiving the standard care only.


In the NOBILITY clinical trial involving 126 participants, the sponsor met the primary endpoint of complete renal response at 52 weeks as well as the secondary endpoint which involved complete and partial renal response and improved serologic markers of disease activity. No additional safety signals were reported.

Roche Strategy to Bolster Revenues

Roche’s CEO Severin Schwan is on the record that they need to augment declining sales of its big three moneymakers including Rituxan, Avastin, and Herceptin as they are subject to a wave of copycat therapies. The boost, the company hopes, will be from products such as Gazyva which has been repurposed for lupus nephritis.