September 18, 2019

The LRA is pleased to share that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to obinutuzumab (Gazyva®) for adults with lupus nephritis – the most common complication of lupus.  The FDA’s designation aims to  speed up  the development and review of drugs intended to treat a serious condition “when “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

Obinutuzumab is an existing drug from the Roche Group that is currently approved by the FDA for treating certain types of cancer. The monoclonal antibody blocks the CD20 protein found in immune B-cells and may prevent the inflammation that marks lupus and other autoimmune diseases.

As reported in a press release issued September 18 by the Roche Group, the Breakthrough Therapy designation was granted based on data from the phase II NOBILITY study in adult patients with proliferative lupus nephritis.

LRA President and CEO Kenneth M. Farber commented, “The breakthrough designation from the FDA should accelerate the development of obinutuzumab for lupus nephritis based on promising Phase 2 trial results. With no treatments currently approved specifically for this common and dangerous complication, this news is particularly welcome.”

The LRA shared the NOBILITY results  in June when they were announced by Roche.  At one year obinutuzumab helped more patients achieve a complete response to treatment when added to standard of care with either mycophenolate mofetil or mycophenolic acid plus corticosteroids than those receiving standard of care alone. In addition to achieving complete response, the study’s primary measurement of the drug’s effectiveness, results also met the secondary endpoints of improved overall response to treatment as well as reduced levels of antibodies in the blood. No new safety issues were seen.

Lupus nephritis is a life-threatening complication of systemic erythematosus lupus (SLE), resulting from inflammation of the kidneys.

Roche plans to begin enrolling patients in a phase III trial next year to test obinutuzumab as a treatment for lupus nephritis.