Positive phase III data for Roche’s Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus

The Phase III ALLEGORY study demonstrated positive results for Gazyva/Gazyvaro in treating systemic lupus erythematosus (SLE). Gazyva/Gazyvaro, an anti-CD20 monoclonal antibody, met its primary endpoint by showing a higher percentage of patients achieving a significant SRI-4 improvement. All key secondary endpoints were also met, indicating Gazyva/Gazyvaro's effectiveness in controlling SLE disease activity. No new safety concerns were identified, with the drug's safety profile remaining consistent. These findings suggest Gazyva/Gazyvaro could become a transformative new standard of care for SLE patients worldwide. The drug directly targets B cells, a key driver of inflammation in SLE. Positive results from this study follow recent approvals for Gazyva/Gazyvaro in lupus nephritis and idiopathic nephrotic syndrome. SLE affects millions globally, primarily women, and often leads to organ damage and potentially life-threatening complications like lupus nephritis. Roche plans to share this data with health authorities, aiming for rapid availability to patients. Gazyva/Gazyvaro's effectiveness in autoimmune diseases is further supported by these promising results.