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About IMAAVY® (nipocalimab-aahu)

MOA
IgG reduction

IMAAVY is a human IgG1 monoclonal antibody that binds to FcRn, resulting in the reduction of circulating IgG levels.1

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IMAAVY is the first and only fully human FcRn-blocking mAb.1,2

IMAAVY is designed for long-lasting, targeted binding.1-3

  • IMAAVY has been proven to bind with high affinity both inside and outside the cell

IMAAVY enables the reduction of circulating IgG levels, including those of pathogenic IgG.2*

Based on in vivo and/or in vitro studies.3 The clinical significance of these characteristics is not fully known.

*

In the Phase 3 pivotal trial, the pharmacological effect of IMAAVY was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels. In patients positive for AChR and MuSK autoantibodies who were treated with IMAAVY, there was a reduction in AChR and MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern.1

IMAAVY + SOC demonstrated IgG reduction over time1

IMAAVY + SOC vs placebo + SOC median percent change in total IgG

The clinical significance of these data has not been established, and comparisons cannot be made.

AChR=acetylcholine receptor; FcRn=neonatal fragment crystallizable receptor; IgG=immunoglobulin G; IQR=interquartile range; mAb=monoclonal antibodies; MuSK=muscle-specific tyrosine kinase; SOC=standard of care.
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References: 1. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8 3. Seth NP, Xu R, DuPrie M, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025;17(1):1–22. doi:10.1080/19420862.2025.2461191