Nipocalimab showed greater sustained disease control versus approved FcRn blockers for generalised myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG

IMAAVY (nipocalimab), an FcRn blocker, received U.S. FDA approval earlier this year for the broad population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and paediatric gMG patients aged 12 and older

BEERSE, BELGIUM , June 23, 2025 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company today announced new data from an indirect treatment comparison (ITC) that showed consistent and sustained disease control with nipocalimab versus other approved FcRn blockers in adults with generalised myasthenia gravis (gMG). These data, featured at the European Academy of Neurology (EAN) 2025 Congress in Helsinki, Finland, are among the 11 abstracts Johnson & Johnson is presenting.¹

Based on the ITC, which included the pivotal Phase 3 Vivacity-MG3 study, nipocalimab showed a comparable onset of symptom relief at Week 1 and showed consistent and sustained disease control with greater or statistically significant improvement of MG-ADL^a scores versus the published Phase 3 data of other marketed FcRn blockers at several timepoints up to 24 weeks^b of treatment. Results were consistent across multiple ITC methods^c.¹

• Population-adjusted ITCs without a common control exhibited significantly greater mean improvements in MG-ADL scores favouring nipocalimab over other FcRn blockers at Weeks 8^d to 24 versus one comparator and at Weeks 10-14^d versus another comparator.¹
• In placebo-adjusted ITCs, nipocalimab was associated with numerically greater efficacy versus one treatment comparator at weeks 8^e and 18-24^e and versus another at Weeks 10-14^e, with statistical significance at Weeks 10^f and 12^f.¹

“These analyses provide useful population-adjusted indirect comparative data and add to the body of evidence supporting the use of nipocalimab for the treatment of gMG for certain patients,” said Saiju Jacob, M.D., Professor, Department of Immunology and Immunotherapy at University of Birmingham and Consultant Neurologist at University Hospitals Birmingham, UK^g. “The significantly greater mean improvements on MG-ADL scores with nipocalimab reflect important new evidence on the ongoing need for sustained disease control in a chronic condition like gMG.”

“Generalised myasthenia gravis (gMG) is characterised by severe muscle weakness and difficulties in speech and swallowing, and so improved control of gMG could mean the difference between a person facing serious difficulty with swallowing and being able to enjoy a meal on their own,” said Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “The encouraging results from the indirect treatment comparison presented at this year’s EAN reinforce J&J’s commitment to broadening the treatment landscape and improving outcomes for people living with this disease.”

ITCs are utilised by regulatory agencies, health technology assessment agencies and medical guideline committees to comparatively evaluate treatment options when there is no or limited availability of evidence on head-to-head clinical trials.² ITCs, however, cannot replace and should not be considered the same as head-to-head clinical trials.² Unanchored population-adjusted and placebo-anchored Bucher ITC methods were used.¹ Unanchored population-adjusted indirect comparisons allow for adjustment of population differences using individual patient-level data from nipocalimab and aggregate data from other approved FcRn blockers.¹ Placebo-anchored Bucher ITCs evaluate a small number of treatments through a common comparator such as the trial placebo using aggregate data from different trials.¹
        
“At Johnson & Johnson, we recognise that for people living with gMG, the goal isn’t just temporary relief, but rather sustained disease control. This analysis provides additional insights into the profile of nipocalimab and highlights its potential as a treatment option for appropriate patients aged 12 and older living with gMG,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Foetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. “As we continue to research the potential impact of nipocalimab and work with regulators worldwide, we are committed to helping patients with chronic, debilitating autoantibody conditions, like gMG.”

Nipocalimab is approved in the U.S. for adult and paediatric patients (12 years of age and older) with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive gMG.³ Johnson & Johnson also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of nipocalimab in gMG in September 2024.⁴

Editor’s notes:

1. 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.⁵  
2. There are no head-to-head data available for any FcRn blockers, and no claim of superiority can be made by any FcRn blockers in the absence of such head-to-head trial data.¹
3. The ITC did not evaluate safety amongst the FcRn blocker agents.¹
4. In unanchored population-adjusted indirect comparison, nipocalimab versus one treatment at Week 8 had a mean difference of -2.36 [(95% confidence interval (CI): -3.56, -1.16); P=0.001]; this trend continued up to Week 24 (P<0.05). For another comparator, at Week 10 nipocalimab had a mean difference of -2.38 at 7mg/kg one comparator dose [(95% CI:-3.57, -1.18); P<0.001] and a mean difference of -3.14 with 10mg/kg of a different comparator dose [(95% CI:-4.15, -2.14); P<0.001]; this trend continued up to Week 14 ( P<0.001).¹
5. In placebo-controlled indirect comparison, MG-ADL change from baseline (CFB) was greater at Week 8 by -1.24 versus one treatment comparator (-95% confidence interval (CI): -2.78, 0.30), at Week 18 by -1.13 (95% CI:-2.77, 0.50), at Week 20 by -1.44 (95% CI: -3.21, -0.33), at Week 22 by -1.79 (95% CI:-4.16, 0.59), and Week 24 by -2.89 (95% CI:-5.67, -0.12).¹
6. In placebo-controlled indirect comparison, treatment with nipocalimab demonstrated a greater MG-ADL CFB versus a comparator dose at Week 10 (mean CFB=-1.19, 95% CI:-2.75, 0.37), Week 12 (mean CFB=-1.41, 95% CI: -2.94, 0.12) and Week 14 (mean CFB=-1.01, 95% CI:-2.51, 0.49). Similar trends were observed for nipocalimab versus a different comparator dose at Week 10 (mean CFB=-2.16, 95% CI:-3.58, -0.73), Week 12 (mean CFB= -1.99, 95% CI:-3.53, -0.45) and Week 14 (mean CFB=-1.12, 95% CI: -2.55, 0.31).¹
7. Dr. Saiju Jacob, M.D. has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.

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.^6,7 The disease impacts between 56,000 and 123,000 people in Europe and an estimated 700,000 people worldwide.^8,9 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.⁸ Roughly 50% of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.^10,11,12 Approximately 10 to 15% of new cases of MG are diagnosed in paediatric patients 12-17 years of age.^13,14,15 Among juvenile MG patients, girls are affected more often than boys with over 65% of paediatric MG cases in the EU diagnosed in girls.^16,17,18

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). This is characterised by severe muscle weakness and difficulties in speech and swallowing.^{19,20,21,22,23} Vulnerable gMG populations, such as paediatric patients, have more limited therapeutic options.²⁴

ABOUT THE INDIRECT TREATMENT COMPARISON
Indirect treatment comparisons (ITCs) were conducted to compare efficacy onset using 1-week timepoint, and for consistency and sustained disease control, comparisons were conducted for multiple timepoints up to 24-weeks for one treatment comparator (3-cycle duration) and up to 14-weeks for another treatment comparator (final visit data reported).¹ The differences in clinical trial design across FcRn blockers coupled with differences in background standard of care (SOC) required multiple indirect treatment comparison methods to be utilised.¹ Therefore, ITCs were conducted using unanchored population-adjusted indirect comparisons (without placebo) and placebo-anchored Bucher method.¹ Differences <0 favoured nipocalimab for all comparisons.¹ The data used in the analysis came from published registrational trials of nipocalimab and comparator FcRn blockers approved to treat gMG.¹

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.^8,25,26 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.^25,26 Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).²⁶ 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.²⁵ A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.²⁵

ABOUT NIPOCALIMAB
Nipocalimab is a monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies that underlie generalised myasthenia gravis (gMG) without additional detectable effects on other adaptive and innate immune functions.^27,28 Nipocalimab is currently approved in the U.S for the treatment of gMG in adults and paediatric patients 12 years of age and older who are AChR or MuSK antibody positive.³

Nipocalimab is continuing to be investigated across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Foetal diseases mediated by maternal alloantibodies and Rheumatic diseases.^{25,29,30,31,32,33,34,35,36,37} The investigational monoclonal antibody is designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) auto and alloantibodies potentially without additional detectable effects on other adaptive and innate immune functions.^27,28

The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) 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 and Sjögren’s disease (SjD) in March 2025
• 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 Sjögren’s disease in November 2024 
• U.S. FDA granted Priority Review in gMG in Q4 2024

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.innovativemedicine.jnj.com/emea/.

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

Janssen-Cilag International NV is a Johnson & Johnson company.

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 nipocalimab. 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 materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson and/or Janssen-Cilag International NV. 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 or on request from Johnson & Johnson. Johnson & Johnson and/or Janssen-Cilag International NV does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Source: Johnson & Johnson

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June 2025 

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CONTACT: Media contact: Alexandra Nisipeanu adridean@its.jnj.com +31627142080

Investor contact: Lauren Johnson investor-relations@its.jnj.com 

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