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

Core Viewpoint - Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) for treating adult patients with active Class III or IV lupus nephritis, with a final decision from the European Commission expected soon [1][2]. Company Overview - Roche is a leading biotechnology company founded in 1896, known for its commitment to developing innovative medicines and diagnostics to improve global health [11]. - The company has a broad pipeline targeting immune drivers of kidney diseases, including systemic lupus erythematosus and lupus nephritis [4]. Product Information - Gazyva/Gazyvaro (obinutuzumab) is a Type II engineered humanized monoclonal antibody that targets CD20 on B cells, which are implicated in kidney damage in lupus nephritis [5]. - The product is already approved in 100 countries for various hematological cancers and is part of a collaboration between Genentech and Biogen in the United States [6]. Clinical Study Results - The recommendation for Gazyva/Gazyvaro is based on positive results from the phase II NOBILITY and phase III REGENCY studies, where 46.4% of participants on Gazyva/Gazyvaro achieved a complete renal response compared to 33.1% on standard therapy alone [2][8]. - The REGENCY study enrolled 271 participants and demonstrated a statistically significant reduction in corticosteroid use and improved disease control [7]. Market Need - Lupus nephritis affects over 1.7 million people worldwide, predominantly women of childbearing age, and currently has no cure [10][9]. - The condition can lead to severe kidney damage and end-stage kidney disease if not effectively managed [9].