Johnson & Johnson Announces IMAAVY (Nipocalimab-Aahu) Shows Over Two Years Of Sustained Disease Control In Generalized Myasthenia Gravis

Published: 2026-04-22 13:36:28 ET JNJ

Published on 04/22/2026 at 01:36 pm EDT

Johnson & Johnson announced new data from the Phase 3 Vivacity-MG3 study and ongoing open label extension (OLE) in a broad population of antibody-positive (including anti-AChR+ and anti-MuSK+) adults with generalized myasthenia gravis (gMG) reinforcing the efficacy, sustained disease control and proven safety profile of IMAAVY (nipocalimab-aahu). Through 120 weeks of follow-up, IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+. Patients achieving sustained minimal symptom expression (MSE) experienced greater improvements in quality of life than those with transient MSE in a post-hoc analysis of the Phase 3 study.

EPIC, the first head-to-head study of IMAAVY versus another FcRn blocker in generalized myasthenia gravis, is now enrolling participants. 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. New post-hoc analyses explore the clinical relevance of sustained minimal symptom expression (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-ADL and QMG scores over time, with mean reductions of 6.47 points on the total MG-ADL and 5.97 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 (32%) 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 =10 or =5 mg/day.

Greater than 64% reduction in total immunoglobulin G (IgG), including pathogenic IgG autoantibodies, the underlying driver of disease. A new post-hoc analysis from the 24-week double-blind portion of the study evaluated the impact of sustained MSE on quality of life (based on MG-QoL-15r measure): Adults who received IMAAVY plus standard of care (SOC) were four times more likely to reach sustained MSE, defined as achieving an MG-ADL score of 0 or 1 and maintaining it for at least 8 weeks, compared to those randomized to placebo. Patients who reached this level and sustainment of symptom control had the largest gains in day-to-day quality of life, compared with those with improvements that were not similarly sustained, or among those who did not attain MSE.

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.