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Obinutuzumab Gets Breakthrough Status for Treatment of Lupus Nephritis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to obinutuzumab (Genentech), a CD20-directed cytolytic antibody, for the treatment of adults with lupus nephritis. The designation was based on data from the phase 2 NOBILITY study that compared the efficacy and safety of obinutuzumab, in combination with mycophenolate mofetil (MMF) or mycophenolic acid…
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