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

Contributing sentiments towards policy:

54% : In October 2025, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval in the European Union, with a final decision expected from the European Commission in the near future.
51% : Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva/Gazyvaro, an anti-CD20 monoclonal antibody designed for enhanced B cell depletionGazyva/Gazyvaro has the potential to be a transformative new standard of care for up to 3.4 million people affected by systemic lupus erythematosus (SLE) worldwideIf approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy for SLE to directly target B cells, a key driver of inflammation and disease activity1These positive results follow the recent US FDA approval and positive EU CHMP opinion for Gazyva/Gazyvaro in lupus nephritis, alongside positive phase III data from the INShore study in idiopathic nephrotic syndrome Basel, 3 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the phase III ALLEGORY study of Gazyva®/Gazyvaro® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy.

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