CHMP recommends EU approval of Roche's Gazyva/Gazyvaro for lupus nephritis

Core Viewpoint - Roche's Gazyva®/Gazyvaro® (obinutuzumab) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with active Class III or IV lupus nephritis, with or without Class V, pending a final decision from the European Commission [1][2]. Summary by Sections Approval and Recommendation - The CHMP has recommended Gazyva/Gazyvaro in combination with mycophenolate mofetil (MMF) for lupus nephritis treatment, with a final decision from the European Commission expected soon [1]. - This recommendation is based on positive results from the phase II NOBILITY and phase III REGENCY studies [2]. Clinical Efficacy - Gazyva/Gazyvaro is the only anti-CD20 antibody to show a complete renal response benefit in a randomized phase III study for lupus nephritis [6]. - In the REGENCY study, 46.4% of participants receiving Gazyva/Gazyvaro plus standard therapy achieved a complete renal response, compared to 33.1% on standard therapy alone [2][5]. - The treatment also resulted in a significant reduction in corticosteroid use and improved proteinuric response, indicating better disease control [2]. Safety Profile - The safety profile of Gazyva/Gazyvaro aligns with its established profile in hematology-oncology indications, suggesting it is well-tolerated [2]. Broader Research and Development - Gazyva/Gazyvaro is under investigation for various conditions, including systemic lupus erythematosus and membranous nephropathy, and is part of Roche's extensive pipeline targeting kidney-related diseases [3][4]. Background on Lupus Nephritis - Lupus nephritis affects over 1.7 million people globally, primarily women of childbearing age, and can lead to severe kidney damage and end-stage kidney disease if untreated [7][6]. - There is currently no cure for lupus nephritis, highlighting the importance of new treatment options like Gazyva/Gazyvaro [7]. Company Overview - Roche, founded in 1896, is a leading biotechnology company focused on developing innovative medicines and diagnostics to improve patient outcomes globally [8].