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Johnson & Johnson presents new IMAAVY®▼ (nipocalimab) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalised myasthenia gravis

2026-06-26T16:45:01Z
  • 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

Safety and tolerability were consistent across all patients in the study and across other nipocalimab studies.7,8,9 The overall incidence of adverse events (AEs) was 84% in both the nipocalimab and the placebo arms and serious adverse events (SAEs) were 9% in the nipocalimab arm compared to 14% in the placebo arm.7 The most common AEs associated with nipocalimab include muscle spasms, peripheral oedema, increased lipids and decreased serum albumin.10,k

Ongoing evidence generation in gMG will also be highlighted, including:

  • Innovative PETUNIA study design: PETUNIA is designed to generate real-world safety data on pregnancy, maternal, and infant outcomes following exposure to nipocalimab during pregnancy.4 By leveraging prospective and retrospective reports the study aims to capture more detailed information on outcomes in this setting, helping to expand the evidence base beyond the traditional post-marketing safety monitoring requirements and support clinical decision-making in an area where current evidence is limited.4,c

“For people living with generalised myasthenia gravis, sustained disease control can mean more than clinical stability - it can support greater confidence through clinically relevant moments in the patient journey,” said Mark Graham Ph.D., Therapeutic Area Head, Immunology, Europe, Middle East and Africa, Johnson & Johnson. “These new Vivacity-MG3 analyses add to the growing evidence supporting nipocalimab across key patient populations and reinforce the importance of continuing to explore outcomes earlier in the generalised myasthenia gravis treatment journey and during episodes that can challenge symptom control, such as illness and infection.”

“People living with generalised myasthenia gravis often face unpredictable symptoms that can interfere with everyday life, underscoring the need for continued innovation grounded in disease biology,” said David Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. “At Johnson & Johnson, we are committed to advancing research in autoantibody diseases to better understand the role of nipocalimab, an FcRn blocker designed to help address the underlying cause of generalised myasthenia gravis, while preserving humoral immune function. We are continuing to explore the potential of nipocalimab in supporting sustained disease control across key moments in patients’ lives.”

Nipocalimab is currently approved as an add-on to standard therapy for the treatment of gMG in adults and adolescent patients aged 12 years of age and older who are anti-AChR or anti-MuSK antibody positive by the European Medicines Agency (EMA), and for adult and paediatric patients (12 years of age and older) with anti-AChR or anti-MuSK antibody positive gMG by the U.S. Food and Drug Administration (FDA).10,11

Editor’s Notes:

  1. Anti-AChR+= anti-acetylcholine receptor positive antibody.
  2. Anti-MuSK+= anti-muscle specific tyrosine kinase positive antibody.
  3. Pregnancy Enhanced Tracking with Neonatal and Infant Assessment (PETUNIA) is a post-marketing FDA requirement.
  4. Dr. Carlo Antozzi has provided consulting, advisory and speaking services to Johnson & Johnson. He has not been paid for any media work.
  5. 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.12
  6. The proportion of patients achieving a meaningful clinical improvement [MCI] is defined as a ≥2-point improvement in MG-ADL score at Week 24.1
  7. At Week 24, patients diagnosed within five years who were treated with nipocalimab plus standard of care (SOC) achieved greater reductions in MG-ADL scores from baseline compared with placebo plus SOC (mean [SD]: -4.9 [2.88] vs -2.7 [2.46]; difference: -2.22 [SE: 0.76]; p=0.005).1
  8. This is based on QMG (Quantitative Myasthenia Gravis) score which is a 13-item assessment by a clinician that quantifies MG disease severity through muscle weakness. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity.12
  9. At Week 24, patients with MG-ADL scores lower than 9 treated with nipocalimab plus SOC achieved greater reductions in MG-ADL scores from baseline compared with placebo plus SOC (mean [SD]: -4.5 [2.64] vs -2.3 [2.37]; difference: -2.23 [SE: 0.588]; p<0.001).2 Additionally, QMG reductions were also greater with nipocalimab plus SOC from baseline compared to placebo plus SOC (mean [SD]: -5.2 [4.45] vs -1.9 [3.69]; difference: -3.38 [SE:0.986]; p=0.001).2
  10. Among patients who experienced an infection/infestation, the median (IQR) change from pre- to post-infection in MG-ADL scores was 0.0 (-1.0 to 1.0) with nipocalimab versus 1.0 (0.0 to 2.0) with placebo; in QMG scores, the median (IQR) change was 0.0 (-1.0 to 2.0) versus 1.0 (-1.0 to 1.0), respectively.3 Overall, infections/infestations were reported in 42.9% of patients in the nipocalimab group (71 events) and 41.8% in the placebo group (59 events).3
  11. Nipocalimab may increase the risk of infection, including serious infections. It is recommended to delay treatment in patients with active infection until resolution.11

ABOUT GENERALISED 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 signalling from nerves to muscles, thus impairing or preventing muscle contraction.13,14 The disease impacts between 56,000 and 123,000 people in Europe and an estimated 700,000 people worldwide.15,16 The disease affects both men and women and occurs across all ages and racial and ethnic groups, but it most frequently starts in young women and older men.15 Roughly 50% of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.17,18,19 Approximately 10 to 15% of new cases of MG are diagnosed in paediatric patients 12-17 years of age.18,20,21,22 Among juvenile MG patients, girls are affected more often than boys, with over 65% of paediatric MG cases in the EU diagnosed in girls.23,24,25

Initial disease manifestations are usually eye-related, but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalised myasthenia gravis (gMG).26,27,28,29,30,31 This is characterised by severe muscle weakness and difficulties in speech and swallowing.27,29,30,31,32,33 Vulnerable gMG populations, such as paediatric patients, have more limited therapeutic options.33

ABOUT THE PHASE 3 VIVACITY-MG3 STUDY
The Phase 3 Vivacity-MG3 study (NCT04951622/2023-504152-97) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high.15,34,35 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.34,35 Randomisation 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.35 Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).35 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.34 A key secondary endpoint included change in Quantitative Myasthenia Gravis (QMG) score.34 Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.36

ABOUT IMAAVY® (nipocalimab)
Nipocalimab is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions.37,38,39 Nipocalimab is currently approved in the European Union as an add-on to standard therapy for the treatment of gMG, in adults and adolescent patients aged 12 years of age and older who are anti-AChR or anti-MuSK antibody positive.10,40

Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Foetal 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 foetus.34,41,42,43,44,45,46,47,48,49

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 haemolytic disease of the foetus and newborn (HDFN) in October 2019 and foetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025
  • U.S. FDA Fast Track designation in HDFN, and warm autoimmune haemolytic anaemia (wAIHA) in July 2019, gMG in December 2021, 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 and wAIHA in Q2 2026

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using nipocalimab please refer to the Summary of Product Characteristics.
  
▼ In line with EU regulations for new medicines, nipocalimab is subject to additional monitoring.

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.  

Learn more at www.jnj.com/innovativemedicine/emea/

Follow us at www.linkedin.com/jnj-innovative-medicine-emea

Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies. 

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

For European medical and trade media only. Not for distribution in the UK, Ireland and BeNeLux

CP-587318
June 2026

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REFERENCES


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