Zhi Tong Cai Jing·2025-10-20 13:13Core Viewpoint - Roche's drug, Ocrelizumab (brand name: Gazyva/Gazyvaro), has received FDA approval for a new indication to treat adult patients with active lupus nephritis (LN) who are undergoing standard treatment [1] Group 1: Drug Approval and Indication - Ocrelizumab is the first CD20-targeted therapy approved by the FDA for the treatment of lupus nephritis [1] - The approval is based on positive results from the Phase II NOBILITY study and the Phase III REGENCY study [1] Group 2: Clinical Study Results - In the REGENCY study, 46.4% of patients receiving Ocrelizumab combined with standard treatment achieved complete renal response (CRR) at week 76, compared to 33.1% in the standard treatment group (adjusted difference of 13.4%, 95% CI: 2.0%-24.8%; P=0.0232) [1] - The Ocrelizumab group also showed clinically meaningful improvements in complement levels, as well as reductions in anti-dsDNA antibodies, disease activity, and inflammatory markers compared to the standard treatment group [1]