Johnson & Johnson to begin FcRn blockers study

Johnson & Johnson announced plans to initiate the first head-to-head study comparing FcRn blockers for patients with generalized myasthenia gravis, or gMG, which aims to affirm IMAAVY, or nipocalimab-aahu, as the FcRn blocker of choice for appropriate gMG patients. The EPIC study design and Vibrance-MG Phase 2/3 long-term extension, or LTE, data are among 38 abstracts the Company will present at the 2025 Myasthenia Gravis Foundation of America, or MGFA, Scientific Session and the American Association of Neuromuscular and Electrodiagnostic Medicine, or AANEM, Annual Meeting. EPIC is a Phase 3b, randomized, open-label study designed to compare FcRn blockers in adults with gMG. The study will evaluate whether treatment with IMAAVY provides superior disease control versus efgartigimod in adults with gMG who have never received an FcRn blocker. It also includes a treatment-switch arm to assess efficacy and safety of IMAAVY in participants switching from efgartigimod to IMAAVY. The study’s key primary and secondary endpoints are change from baseline in total immunoglobulin G, or IgG, levels and sustained disease control measured by MG-ADLa and QMGb scores 8-12 weeks post-initiation of treatment, respectively. The announcement of the EPIC study is accompanied by new positive data from the Vibrance-MG Phase 2/3 LTE study. These new data show treatment with IMAAVY plus standard of care in pediatric patients aged 12 and older with gMG demonstrated sustained reductions in IgG through 72 weeks, disease control, functional improvements and long-term safety. New data show that treatment with IMAAVY(TM) led to a rapid and sustained reduction in IgG levels – with a median reduction of ~73% by Week 24.2 Improvements in both daily functionc and muscle strengthd were also observed through 72 weeks, indicating sustained disease control over time. The treatment was generally well tolerated and no new safety concerns have emerged thus far during extended follow-up. These findings are consistent with the positive results from the pivotal Vivacity-MG3 study and ongoing open-label extension in adult patients with gMG. Together, the data highlight the differentiated treatment profile of IMAAVYacross key antibody subtypes (anti-acetylcholine receptor and the potential to provide long-term sustained disease control for the broadest population of people living with gMG.