IMAAVY™

(nipocalimab-aahu)

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IMAAVY™ (nipocalimab-aahu)

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IMAAVY - Comparison to Other Neonatal Fragment Crystallizable Receptor Blockers in Patients with Generalized Myasthenia Gravis

Last Updated: 05/08/2026

SUMMARY

The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
EPIC (NCT07217587) is an ongoing phase 3b, multicenter, randomized, open-label, active-controlled interventional study with a parallel-group design, including treatment switching in adults with generalized myasthenia gravis (gMG), that will evaluate the efficacy of IMAAVY vs efgartigimod in patients initiating neonatal fragment crystallizable receptor (FcRn)-targeted therapy. The study will also assess the efficacy and safety of IMAAVY in patients switching from efgartigimod to IMAAVY.¹

Clinical data

Phase 3 Study: EPIC

This is an ongoing, open-label, active-controlled, multicenter, randomized phase 3b, interventional clinical trial with a parallel-group design, including treatment switching in adults with gMG, evaluating the efficacy of IMAAVY vs efgartigimod in patients initiating FcRn-targeted therapy. The study will also assess the efficacy and safety of IMAAVY in patients switching from efgartigimod to IMAAVY.¹

Study Design/Methods

The key inclusion and exclusion criteria are described in the following Table: Select Inclusion/Exclusion Criteria in the EPIC Study.

Select Inclusion/Exclusion Criteria in the EPIC Study¹

Inclusion Criteria	Exclusion Criteria
Adults ≥18 and <75 years Diagnosis of gMG MGFA Class II a/b, III a/b, or IV a/b at screening Positive anti-AChR antibody MG-ADL score ≥5 with ≥50% non-ocular Arms 1 and 2 only Suboptimal response to current stable therapy^a for gMG (per investigator) Total IgG ≥6 g/L at screening Arm 3 only Treatment with efgartigimod IV or SC for ≥1 cycle, with the final cycle per local label Patient and HCP agree on switch to IMAAVY	Received rituximab within 24 weeks prior to baseline Received plasmapheresis, immunoadsorption therapy, or IVIG within 4 weeks prior to baseline Arms 1 & 2 Prior treatment for MG with an FcRn-targeting therapy Currently taking IgG monoclonal antibody therapeutics or Fc-conjugated therapeutic agents (including factor/enzyme replacement) Arm 3 Currently taking IgG monoclonal antibody therapeutics or Fc-conjugated therapeutic agents (including factor/enzyme replacement), except efgartigimod
Abbreviations: AChE, acetylcholinesterase, anti-AChR, anti-acetylcholine receptor; Fc, fragment crystallizable, FcRn, neonatal Fc receptor; gMG, generalized myasthenia gravis; HCP, healthcare professional; IgG, immunoglobulin G; IV, intravenous; IVIG, intravenous immunoglobulin; MG, Myasthenia Gravis; MG-ADL, Myasthenia Gravis Activities of Daily Living; MGFA, Myasthenia Gravis Foundation of America; SC, subcutaneous. ^aStable therapy is defined as: 1) if taking an AChE inhibitor, receiving a stable dose and regimen for ≥2 weeks prior to baseline, 2) if taking a glucocorticosteroid, receiving a stable dose and regimen for ≥3 weeks prior to baseline, or 3) if currently receiving immunosuppressants, receiving the given immunosuppressant for ≥24 weeks and on a stable dose for ≥12 weeks prior to baseline. Allowed concomitant immunosuppressants are azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, cyclosporine, tacrolimus, or cyclophosphamide.

Inclusion Criteria

Exclusion Criteria

Adults ≥18 and <75 years
Diagnosis of gMG MGFA Class II a/b, III a/b, or IV a/b at screening
Positive anti-AChR antibody
MG-ADL score ≥5 with ≥50% non-ocular

Arms 1 and 2 only

Suboptimal response to current stable therapy^a for gMG (per investigator)
Total IgG ≥6 g/L at screening

Arm 3 only

Treatment with efgartigimod IV or SC for ≥1 cycle, with the final cycle per local label
Patient and HCP agree on switch to IMAAVY

Received rituximab within 24 weeks prior to baseline
Received plasmapheresis, immunoadsorption therapy, or IVIG within 4 weeks prior to baseline

Arms 1 & 2

Prior treatment for MG with an FcRn-targeting therapy
Currently taking IgG monoclonal antibody therapeutics or Fc-conjugated therapeutic agents (including factor/enzyme replacement)

Arm 3

Currently taking IgG monoclonal antibody therapeutics or Fc-conjugated therapeutic agents (including factor/enzyme replacement), except efgartigimod

Abbreviations: AChE, acetylcholinesterase, anti-AChR, anti-acetylcholine receptor; Fc, fragment crystallizable, FcRn, neonatal Fc receptor; gMG, generalized myasthenia gravis; HCP, healthcare professional; IgG, immunoglobulin G; IV, intravenous; IVIG, intravenous immunoglobulin; MG, Myasthenia Gravis; MG-ADL, Myasthenia Gravis Activities of Daily Living; MGFA, Myasthenia Gravis Foundation of America; SC, subcutaneous.
^aStable therapy is defined as: 1) if taking an AChE inhibitor, receiving a stable dose and regimen for ≥2 weeks prior to baseline, 2) if taking a glucocorticosteroid, receiving a stable dose and regimen for ≥3 weeks prior to baseline, or 3) if currently receiving immunosuppressants, receiving the given immunosuppressant for ≥24 weeks and on a stable dose for ≥12 weeks prior to baseline. Allowed concomitant immunosuppressants are azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, cyclosporine, tacrolimus, or cyclophosphamide.

The study consists of a screening period of up to 32 days followed by a 12-week, randomized, open-label, head-to-head phase (Arms 1 and 2) or an up to 12-week run-in phase followed by a 12-week, open-label treatment switch phase (Arm 3), and an 8-week safety follow-up phase. For study design/methods, see Figure: EPIC Study Design.

EPIC Study Design²

Abbreviations: D, day; IV, intravenous; MG-ADL, Myasthenia Gravis Activities of Daily Living; SC, subcutaneous; SD, switch day; SW, switch week; W, week.

The primary and key secondary endpoints across EPIC trial are described in Table: Key Endpoints in the EPIC Trial.

Key Endpoints in the EPIC Trial¹^,²

Study Phase	Primary Endpoint	Time Frame
Head-to-Head Phase	Averaged mean percent CFB in total IgG^a between Arms 1 and 2	Weeks 8 to 12
Study Phase	Key Secondary Endpoints	Time Frame
Head-to-Head Phase	Averaged mean CFB in MG-ADL^a and QMG^a total score between Arms 1 and 2	Weeks 8 to 12
	Mean CFB in MG-ADL^a and QMG^a total score between Arms 1 and 2	Week 8
	Mean percent CFB in total IgG^a in Arms 1 and 2	Week 8
	Mean CFB in MG-ADL total score, QMG total score, and total IgG between Arm 1 at EoT and Arm 2 at EoC based on clinical evaluation^b	EoT (arm 1) EoC (arm 2)
Treatment Switch Phase	Mean percent change in total IgG and mean change in MG-ADL total score from pre IMAAVY exposure (SD1) to end of IMAAVY study treatment (SW12/EoT) in Arm 3	EoT
Abbreviations: CFB, change from baseline; EoC, end of cycle; EoT, end of treatment; IgG, immunoglobulin G; MG, myasthenia gravis; MG-ADL, Myasthenia Gravis Activities of Daily Living; QMG, Quantitative Myasthenia Gravis; SD1, switch day 1; SW12, switch week 12. ^aType I error rate controlled at the 2-sided 0.05 significance level using fixed sequence gatekeeper approach and Hochberg step-up procedure. ^bEoC based on clinical evaluation is defined as the timepoint after the fourth dose of efgartigimod when, based on MG-ADL score clinical criteria, the treatment decision would be made to start a second cycle of efgartigimod, an MG rescue medication, or week 12/EoT, whichever occurs first.

Key safety endpoints included the percentage of patients with ≥1 adverse event (AE), serious AE, or AE of special interest (infection, venous thromboembolism, and hypoalbuminemia ≥grade 3) and descriptive analyses of abnormal laboratory tests, vital signs, and physical examination findings.
All efficacy and safety analyses will be based on the full analysis sets:
- Arms 1 and 2: All randomized participants who received ≥1 dose (partial or complete) of any study intervention
- Arm 3: All participants who received ≥1 dose (partial or complete) of IMAAVY on or after switch day 1
Additional details regarding the EPIC study can be found on clinicaltrials.gov.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 16 March 2026.

Summarized in this response are relevant data from head-to-head, randomized controlled clinical trials in adult patients with gMG.

References

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1	Muppidi S, Corse A, Wiendl H, et al. Efficacy and safety of nipocalimab vs efgartigimod in a randomized, open-label, phase 3b, interventional trial including within class switching from efgartigimod to nipocalimab (EPIC): study design. Poster presented at: AANEM Annual Meeting; October 29-November 1, 2025; San Francisco, CA.
2	Muppidi S, Corse A, Wiendl H, et al. Efficacy and safety of nipocalimab vs efgartigimod in a randomized, open-label, phase 3b, interventional trial including within-class switching from efgartigimod to nipocalimab (EPIC): study design. Poster presented at: Muscular Dystrophy Association (MDA) Clinical and Scientific Conference; March 8–11, 2026; Orlando, FL, USA.