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Roche :FDA Grants Breakthrough Therapy Designation For Gazyva In Lupus Nephritis

Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to Gazyva or obinutuzumab for adults with lupus nephritis.

Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys and is associated with a high risk of end-stage renal disease or death.

Lupus nephritis overwhelmingly impacts women, particularly young women of color. About 90% of those diagnosed with lupus are women, and African American, Hispanic, Native American and Asian American women are two to three times more likely than Caucasian women to get lupus.

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