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Roche's autoimmune disease therapy Gazyva gets US FDA breakthrough status

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Roche Holding AG's Genentech Inc. unit said the U.S. Food and Drug Administration granted breakthrough therapy designation to Gazyva to treat adults with lupus nephritis.

Lupus nephritis is a complication of systemic lupus erythematosus, or SLE, an autoimmune disease in which the immune system targets healthy cells and organs, resulting in inflammation of the kidneys and potentially leading to kidney failure.

The agency's designation is based on a mid-stage study called Nobility, results of which showed that Gazyva, or obinutuzumab, combined with standard of care treatment improved kidney function in patients with lupus nephritis.

Lupus nephritis mostly affects women, particularly young women of color. African American, Hispanic, Native American and Asian American women are up to three times more likely than Caucasian women to get lupus.

About 1.5 million people in the U.S. are affected by lupus, with about 70% of cases representing SLE. Up to 60% of people with SLE will develop lupus nephritis.

There is no cure for lupus or lupus nephritis.