Roche(US:RHHBY) Globenewswire·2025-12-09 06:00Core Viewpoint - Roche's Gazyva®/Gazyvaro® (obinutuzumab) has received European Commission approval for treating adult patients with active Class III or IV lupus nephritis, potentially establishing a new standard of care in Europe [1][2]. Group 1: Approval and Impact - The approval is a significant advancement for lupus nephritis treatment in Europe, aiming to delay or prevent progression to end-stage kidney disease [2]. - Gazyva/Gazyvaro demonstrated a complete renal response in 46.4% of patients compared to 33.1% on standard therapy alone, indicating its efficacy [2][5]. - The treatment could benefit approximately 135,000 individuals in the European Union currently living with lupus nephritis [5]. Group 2: Clinical Studies - The approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies, with REGENCY showing statistically significant improvements in renal response and reduced corticosteroid use [2][6]. - The REGENCY study involved 271 participants and was designed to reflect real-world lupus nephritis populations [6]. Group 3: Disease Context - Lupus nephritis is a serious condition affecting predominantly women of color and childbearing age, with a significant risk of progressing to end-stage kidney disease [7]. - Current treatments leave up to one-third of patients progressing to end-stage kidney disease within 10 years, highlighting the need for effective new therapies [7]. Group 4: Future Investigations - Gazyva/Gazyvaro is under investigation for use in children and adolescents with lupus nephritis and adults with membranous nephropathy, indicating Roche's commitment to advancing treatments in immune-mediated diseases [3][4].