Core 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]

Core Viewpoint - Novartis has announced positive data regarding its monoclonal antibody Kesimpta for treating relapsing multiple sclerosis (RMS), demonstrating long-lasting efficacy and safety in patients [1][2]. Group 1: Efficacy of Kesimpta - In a 3b phase study (ARTIOS), patients with RMS who switched to Kesimpta after inadequate response to other treatments showed a significantly low annualized relapse rate (ARR) of only 0.06 at 96 weeks [1]. - Over 90% of participants in the study exhibited no evidence of disease activity (NEDA-3) as assessed by MRI, indicating nearly complete suppression of disease activity [1][2]. - In the ALITHIOS study, more than 90% of treatment-naive RMS patients achieved NEDA-3 after 7 years of continuous Kesimpta treatment, further confirming its durable efficacy [2]. Group 2: Safety Profile - The transition to Kesimpta did not reveal any new safety concerns, regardless of the last disease-modifying therapy (DMT) the patients received [1][2]. - The overall population and treatment-naive patients demonstrated good safety characteristics throughout the studies, with no new safety issues reported [2]. Group 3: Product Information - Kesimpta is a fully humanized monoclonal antibody targeting CD20, which works by depleting B cells from circulation [2]. - It received FDA approval in 2020 for treating relapsing adult multiple sclerosis patients and is notable for being the first B-cell targeted therapy that allows patients to self-administer monthly injections at home using an auto-injector [2].

Core Insights - Novartis announced positive data regarding its monoclonal antibody Kesimpta (ofatumumab) for relapsing multiple sclerosis (RMS), demonstrating sustained efficacy for up to 7 years [1][2] Group 1: Efficacy Data - In a 3b phase study (ARTIOS), patients who switched to Kesimpta after experiencing disease activity on other treatments showed a significantly low annualized relapse rate (ARR) of only 0.06 at 96 weeks [1] - Over 90% of participants in the ARTIOS study exhibited no evidence of disease activity (NEDA-3) as assessed by MRI [1] - In the ALITHIOS study, more than 90% of treatment-naive RMS patients achieved NEDA-3 by the seventh year, indicating the long-term effectiveness of Kesimpta [2] Group 2: Safety Profile - No new safety issues were observed in patients switching to Kesimpta, regardless of their previous disease-modifying therapy (DMT) [1][2] - The therapy demonstrated good safety characteristics in both the overall population and treatment-naive patients [2] Group 3: Product Information - Kesimpta is a fully humanized monoclonal antibody targeting CD20, approved by the FDA in 2020 for treating relapsing adult multiple sclerosis patients [2] - It is the first B-cell targeted therapy that allows patients to self-inject at home monthly using an auto-injector, enhancing disease management convenience [2]