IMAAVY (nipocalimab)▼shows over two years of sustained disease control in a broad population with generalised myasthenia gravis (gMG)
April 22, 2026 – Clinical Trials, Drug Discovery, Other, Pharmaceutical – Johnson & Johnson, clinical trials, generalised myasthenia gravis, neurology, real-world data
- Through 120 weeks of follow-up, nipocalimab 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, a head-to-head study, will compare nipocalimab versus another FcRn blocker in generalised myasthenia gravisa.
22 April 2026 — Beerse, Belgium — Johnson & Johnson today 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+b and anti-MuSK+c) adults with generalised myasthenia gravis (gMG) reinforcing the efficacy, sustained disease control, and safety profile of IMAAVY▼(nipocalimab). These data are among the seven abstracts Johnson & Johnson is presenting at the American Academy of Neurology (AAN) 2026 Meeting in Chicago, Illinois.
“For people living with gMG, consistent and durable symptom control is the central goal of treatment,” said Constantine Farmakidis M.D., Associate Professor of Neurology at the University of Kansas Medical Centerd. “These long-term results, now extending to beyond two years, provide further evidence that disease control, as initially observed in the nipocalimab phase 3 pivotal study, can be sustained, and add to the body of evidence that may help guide clinical decision-making.”
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. In addition, 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.
Long-Term Data from OLE Phase
After the 24-week double-blind phase of the study, patients entered the ongoing OLE phase, with the latest results reflecting a maximum 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, nipocalimab demonstrated:
- Sustained improvements in MG-ADLe and QMGf scores over time, with mean reductions of 6.47g points on the total MG-ADL (standard error [SE]=1.20, p<0.001) and 5.97g points (SE=1.28, p<0.001) on the total QMG scales – measures of MG symptom impact on daily living and muscle strength
- Half of patients achieved MSE (n=153) and nearly one-third (32%) achieved sustained MSE for at least 8 weeks on nipocalimab 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%g reduction in total immunoglobulin G (IgG), including pathogenic IgG autoantibodies, the underlying driver of disease (n=31, standard deviation [SD]=12.91)
- There were no unexpected adverse events (AEs) during the OLE. The most common AEs associated with nipocalimab include muscle spasms, peripheral oedema, increased lipids and decreased serum albumin.
“These long-term findings for nipocalimab reflect continued momentum in transforming the treatment landscape for people living with generalised myasthenia gravis,” said Mark Graham, Therapeutic Area Head, Immunology, Europe, Middle East and Africa Johnson & Johnson. “Evidence demonstrating sustained disease control alongside sustained improvements in quality of life underscores our progress toward more effective treatment options. We remain committed to advancing innovative approaches that address persistent unmet needs and improve long-term outcomes for patients.”
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