CHMP recommends EU approval of Roche's Gazyva/Gazyvaro for lupus nephritis
Positive recommendation based on phase II NOBILITY and phase III REGENCY data showing Gazyva/Gazyvaro’s superiority over standard therapy alone1,2 Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study2Lupus nephritis is a debilitating condition that severely impacts a person’s quality of life and affects more than 1.7 million people worldwide3,4 Basel, 17 October, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ...