US-based biotechnology company Genentech announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for Gazyva (obinutuzumab) used in treating adults with lupus nephritis.

Genentech said that based on data from the Phase II NOBILITY study in adult patients with proliferative lupus nephritis the regulatory body has granted the designation.

In addition, the study of Gazyva in combination with standard of care, using mycophenolate mofetil or mycophenolic acid and corticosteroids, showed enhanced efficacy compared to placebo combined with standard of care alone.

Genentech chief medical officer and global product development head Sandra Horning said: “New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women. We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a Phase III trial next year.”

Lupus nephritis is a severe and potentially mortal disorder of the kidneys

Lupus nephritis is an autoimmune disease condition of systemic lupus erythematosus (SLE), where the patient’s own immune system attacks healthy cells and organs.

Lupus nephritis is prevalent in women, and especially in coloured young women. Approximately 90% of the people diagnosed with lupus are women, of which African American, Hispanic, Native American and Asian American women are two to three times more likely to get lupus compared with Caucasian women. Genentech said that currently there is no cure for lupus or lupus nephritis.

Gazyva, which is part of a collaboration between Genentech and Biogen, is an engineered monoclonal antibody believed to attack the targeted cells both directly and together with the body’s immune system. It attaches to CD20, a protein found only on certain types of B-cells of the immune system.

Genentech claims that it is committed to addressing barriers to clinical trial participation and advancing inclusive research to create new standards for clinical studies.

Furthermore, it is planning to recruit a broader, more diverse population of participants into clinical trials, including diseases such as lupus nephritis, to ensure clinical trial participants more closely reflect those impacted by the disease for which a medicine is being studied.