Drug Approval | December 11, 2025
Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000
The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
CMG1A46 is an investigational T cell-engager with potential to deeply deplete uncontrolled B cells present in autoimmune diseases such as lupus
Focused medicines company delivering strong operational performance. Building depth in five core therapeutic areas, strength in technology platforms, and a balanced geographic footprint
Subscribe To Our Newsletter & Stay Updated
