J&J(US:JNJ) Prnewswire·2025-10-29 12:05Core Insights - Johnson & Johnson announced the initiation of the EPIC study, a Phase 3b trial comparing IMAAVY™ (nipocalimab-aahu) with efgartigimod in adults with generalized myasthenia gravis (gMG) [1][3] - New data from the Vibrance-MG study showed that pediatric patients treated with IMAAVY™ experienced a sustained reduction in immunoglobulin G (IgG) levels over 72 weeks, indicating effective disease control [1][4] - IMAAVY™ is the only FcRn blocker approved for both adult and pediatric gMG patients aged 12 and older, demonstrating sustained disease control [1][7] Study Details - The EPIC study is designed to evaluate the efficacy of IMAAVY™ compared to efgartigimod in adults with gMG who have not previously received FcRn blockers, including a treatment-switch arm [2][3] - Key endpoints of the EPIC study include changes in total IgG levels and sustained disease control measured by MG-ADL and QMG scores 8-12 weeks post-treatment initiation [2] Pediatric Study Findings - The Vibrance-MG Phase 2/3 long-term extension study reported a median reduction of approximately 73% in IgG levels by Week 24, with sustained improvements in daily function and muscle strength observed through 72 weeks [4][6] - These findings highlight the potential of IMAAVY™ to provide long-term disease control for pediatric patients with gMG, a historically underserved population [6][7] Regulatory Status - IMAAVY™ is currently approved by the U.S. FDA for treating gMG in patients aged 12 and older who are anti-AChR or anti-MuSK antibody positive, with ongoing reviews for approval in other regions [7][8] Broader Implications - The data from both the EPIC and Vibrance-MG studies underscore the differentiated treatment profile of IMAAVY™ across various antibody subtypes, suggesting its potential for long-term disease management in a broad population of gMG patients [5][6]