Johnson & Johnson reports new data from Phase 3 Vivacity-MG3 study

Johnson & Johnson announced new data from the Phase 3 Vivacity-MG3 study and ongoing open label extension, or OLE, in a broad population of antibody-positive, or including anti-AChR+a and anti-MuSK+b, adults with generalized myasthenia gravis, or gMG, reinforcing the efficacy, sustained disease control and proven safety profile of IMAAVY, or nipocalimab-aahu. These data are among the seven abstracts Johnson & Johnson is presenting at the American Academy of Neurology, or AAN, 2026 Meeting in Chicago, Illinois. Sustained disease control is a key treatment objective in gMG, as long-term maintenance of low disease activity can help prevent exacerbations, reduce treatment burden and support meaningful function outcomes.i In addition, new post-hoc analyses explore the clinical relevance of sustained minimal symptom expression, or MSE, an emerging patient-centric treatment goal that reflects minimal day-to-day disease impact for people living with gMG. After the 24-week double-blind phase of the study, patients entered the ongoing OLE phase, with the latest results reflecting a total of 120 weeks of observation – among the longest follow-up periods reported for any FcRn blocker study in gMG. At 96 weeks in the OLE, IMAAVY demonstrated: Sustained improvements in MG-ADLd and QMGe scores over time, with mean reductions of 6.47f points on the total MG-ADL and 5.97f points on the total QMG scales – measures of MG symptom impact on daily living and muscle strength; Half of patients achieved MSE and nearly one-third achieved sustained MSE for at least 8 weeks on IMAAVY treatment; incremental reduction of corticosteroid use was also observed through the OLE, with 57% of patients reaching low doses of less than or equal to10 or less than or equal to5 mg/day; greater than 64%f reduction in total immunoglobulin G (IgG), including pathogenic IgG autoantibodies, the underlying driver of disease. Additionally, Johnson & Johnson previously announced plans to initiate EPIC in 2025, the first open-label study designed to compare FcRn blockers in adults with gMG who have never received an FcRn blocker. The study, comparing the efficacy of IMAAVY versus efgartigimod, is now enrolling participants.