FDA accepts application for Roche’s Gazyva/Gazyvaro for most common form of lupus

 

• Filing acceptance based on phase III ALLEGORY data for Gazyva/Gazyvaro showing a significant reduction in disease activity compared with placebo in people with systemic lupus erythematosus (SLE)
• If approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy to directly target B cells in SLE, potentially becoming the new standard of care for this condition1
• 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
• https://www.roche.com/media/releases/med-cor-2026-04-21