Roche's Genentech Gets FDA Supplemental Biologics License Application Acceptance For Gazyva In Systemic Lupus Erythematosus After Phase III ALLEGORY Trial Success
Filing acceptance based on Phase III ALLEGORY data for Gazyva showing a significant reduction in disease activity compared with placebo in people with systemic lupus erythematosus (SLE)
If approved, Gazyva would be the first anti-CD20 therapy to directly target B cells in SLE, potentially becoming the new standard of care for this condition
SLE is a potentially life-threatening autoimmune disease affecting more than three million people worldwide – achieving better disease control can reduce flares and may prevent irreversible organ damage
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