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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+
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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
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EPIC, the first head-to-head study of IMAAVY versus another FcRn blocker in generalized myasthenia gravis, is now enrolling participants
HORSHAM, Pa. (April 22, 2026) – Johnson & Johnson (NYSE: JNJ) 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+a and anti-MuSK+b) adults with generalized myasthenia gravis (gMG) reinforcing the efficacy, sustained disease control and proven safety profile of IMAAVY® (nipocalimab-aahu). 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, MD, Associate Professor of Neurology at the University of Kansas Medical Centerc. “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.i 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.ii
Long-Term Data from OLE Phaseiii
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 (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%f reduction in total immunoglobulin G (IgG), including pathogenic IgG autoantibodies, the underlying driver of disease.
Minimal Symptom Expression Data from Double-Blind Phaseiv
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‑15rg measure):
· Adults who received IMAAVY plus standard of care (SOC)h 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.
“As demonstrated in our pivotal trial, IMAAVY was shown to deliver sustained disease control in a broad population of people living with gMG, helping to address a critical unmet need,” said Chris Gasink, MD, Vice President, Medical Affairs, Autoantibody & Gastroenterology, Johnson & Johnson. “These data reinforce our confidence in IMAAVY and our commitment to delivering treatments that can help more people living with gMG achieve meaningful, lasting disease control.”
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.
For a full list of all Johnson & Johnson data being presented at AAN 2026 visit: https://www.jnj.com/innovativemedicine/neuroscience/myasthenia-gravis.
Editor’s Notes:
a. AChR+ = anti-acetylcholine receptor positive antibody
b. MUsK+ = anti-muscle specific tyrosine kinase positive antibody
c. Constantine Farmakidis, MD, has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.
d. MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient’s recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.v
e. QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicate greater disease severity.vi
f. Results reflect patients receiving IMAAVY and SOC throughout both the 24-week double-blind phase and OLE phase of the study.
g. As measured by MG-QoL-15r (Myasthenia Gravis Quality of Life 15-item Scale – Revised), a scale designed to assess important aspects of the patient’s experience related to MG.vii
h. Standard of care was defined as a stable dose of current gMG treatment, including acetylcholinesterase inhibitors, glucocorticosteroids or immunosupressants (ie, azathioprine, mycophenolate mofetil or mycophenolic acid, methotrexate, ciclosporin, tacrolimus, or cyclophosphamide).viii
ABOUT GENERALIZED MYASTHENIA GRAVIS (gMG)
Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.ix,x,xi The disease impacts an estimated 700,000 people worldwide.vii The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.xii Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.xiii,xiv,xv Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.xvi,xvii,xviii Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls.xix,xx,xxi
Initial disease manifestations are usually eye-related but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness and difficulties in speech and swallowing.xxii,xxiii,xxiv,xxv,xxvi Approximately 100,000 individuals in the U.S. are living with gMG.xxvii Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.xxviii
ABOUT THE PHASE 3 VIVACITY-MG3 STUDY
The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.xxix,xxx Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC. xxvii Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).xxvii The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score. xxvii A key secondary endpoint included change in Quantitative Myasthenia Gravis (QMG) score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.xxviii
ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block FcRn, reducing circulating IgG antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.xxxi
Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.xxxii,xxxiii,xxxiv,xxxv,xxxvi,xxxvii,xxxviii,xxxix,xl
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:
EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025
U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia (FNAIT) in March 2024, Sjögren’s disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026
U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024
U.S. FDA granted Priority Review in gMG in Q4 2024
The legal manufacturer for IMAAVY is Janssen Biotech, Inc.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
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xxx ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622 Last accessed: October 2025.
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xxxiii ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: October 2025.
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xxxviii ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: October 2025.
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