The US Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab), developed by Genentech, for the treatment of adults with lupus nephritis (LN), also known as lupus-related kidney disease.

Gazyva, a type II humanized anti-CD20 monoclonal antibody, works by targeting and eliminating certain B cells, which are believed to promote inflammation which causes kidney damage in LN.

Lupus nephritis affects up to 60 percent of people with lupus and can cause permanent kidney damage or kidney failure if not properly managed.

Louise Vetter, President & CEO, Lupus Foundation of America, commented, "The FDA's approval of Gazyva to treat lupus nephritis is an exciting milestone that illustrates medical advances in treatment options for those living with this debilitating, chronic condition."

The FDA approval follows positive results from the Phase II NOBILITY and Phase III REGENCY trials. In the REGENCY trial, nearly half of those treated with Gazyva in addition to standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response, indicating normal kidney function with little to no protein in the urine. This was significantly higher compared to those treated with standard therapy alone.

For eligible patients living with lupus nephritis, Gazyva can be administered twice yearly following four initial doses in the first year.

Headquartered in South San Francisco, California, Genentech is a member of the Roche Group that develops medicines to treat patients with serious and life-threatening medical conditions.