New analyses from the Phase 3 Vivacity-MG3 study support the impact of nipocalimab in anti-AChR+a, anti-MuSK+b adult patients with generalised myasthenia gravis (gMG) including those early in their disease, participants with lower symptom burden and those who experienced common infections
To address an important evidence gap, the PETUNIAc study design will be presented – demonstrating the innovative way pregnancy outcomes data will be collected following treatment with nipocalimab
Nipocalimab, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with generalised myasthenia gravis (gMG)
BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced new data across 12 abstracts at the European Academy of Neurology (EAN) 2026 Congress that offer additional insight into the use of IMAAVY®▼(nipocalimab) throughout clinically relevant points in the generalised myasthenia gravis (gMG) treatment journey. The analyses include adults with anti-AChRa or anti-MuSKb antibody-positive gMG who were early in their disease course or had lower baseline symptom burden – providing insight into the potential importance of addressing pathogenic immunoglobulin G (IgG) early in disease progression where use of advanced therapies may be less common.1,2 Additional research to be shared include outcomes shortly after common infections, which are a known cause of disease exacerbations in gMG, and plans to address evidence gaps in the use of nipocalimab during pregnancy.3,4
"For many people living with generalised myasthenia gravis, achieving and maintaining sustained disease control is an important goal throughout the course of their disease, from the moment they are diagnosed and across the different stages of their journey," said Carlo Antozzi, M.D., Neurological Institute Foundation C. Besta of Milan, Italy.d "These post-hoc analyses add to the growing body of evidence on nipocalimab, which is designed to selectively target and bind the neonatal Fc receptor with high affinity, and reduce pathogenic immunoglobulin G autoantibodies associated with generalised myasthenia gravis."
Post-hoc analyses from the pivotal Vivacity-MG3 study in adults with antibody positive gMG (spanning anti-AChR+ and anti-MuSK+) will be presented which provide new insights that could inform clinical care including:
Patients early in their disease course (within five years of diagnosis) show improved outcomes: Nipocalimab plus standard of care (SOC) showed greater reductions in MG-ADLe scores versus placebo plus SOC (mean [standard deviation (SD)]: -4.9 [2.88] vs. -2.7 [2.46]; difference: -2.22 [standard error (SE)]: 0.76; p=0.005) at Week 24, with a greater proportion receiving nipocalimab also achieving the stringent measure of sustained meaningful clinical improvement (MCI)f for ≥20 weeks compared to placebo.1,5 Nipocalimab is the only FcRn blocker evaluated to demonstrate sustained MCI over this duration in the double-blind phase of its pivotal study.5,g
Patients with lower baseline symptom burden: Nipocalimab plus SOC decreased symptom severityh (QMG scores: mean [SD]: -5.2 [4.45] vs -1.9 [3.69]); difference: -3.38 [SE:0.986]; p=0.001) and improved daily functioning at Week 24 versus placebo plus SOC (MG-ADL scores: mean [SD]: -4.5 [2.64] vs. -2.3 [2.37]; difference: -2.23 [SE: 0.588]; p<0.001).2 A greater proportion of patients receiving nipocalimab also achieved sustained MCI in this setting, adding further insights for healthcare professionals into the use of nipocalimab in patients with less severe disease.6,i
Patients after contracting common infections: In the nipocalimab arm, observed symptom improvements were maintained within two weeks after patients contracted common infections, providing data on the use of nipocalimab after periods when the likelihood of disease exacerbations is elevated.3,j,k