Imaavy(Nipocalimab)

Immunology· 820 cited findings· 1 source document

What the regulatory reviews say

Imaavy (Nipocalimab) is indicated as an add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. The recommended initial dose is 30 mg/kg, followed by a maintenance dose of 15 mg/kg every 2 weeks. The drug was submitted for regulatory review on 13 September 2024, with a positive CHMP opinion adopted on 3 November 2025.

In efficacy trials, Nipocalimab demonstrated a mean IgG change from baseline of -69.7% with a 15 mg/kg maintenance dose. The LS mean change from baseline in MG-ADL total score for Nipocalimab was -4.68, compared to -3.29 for placebo, resulting in an LS mean difference of -1.39 (p-value = 0.003). For the QMG total score, the LS mean change from baseline for Nipocalimab was -4.77, compared to -1.90 for placebo, with a between-group difference of -2.87 (p-value <0.001).

Safety findings included a 49.5% incidence of treatment-emergent anti-drug antibodies (ADA). Co-administration of Nipocalimab with Fremanezumab resulted in a 66% decrease in Fremanezumab AUC when administered on the same day. There was also a mean percent reduction of albumin from baseline values of -7.2%.

Key figures — cited to the source page

LS mean difference in MG-ADL total score (Nipocalimab vs Placebo)	-1.39	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.95
P-value for MG-ADL total score difference	0.003	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.95
Between-group difference in QMG total score change (Nipocalimab vs Placebo)	-2.87	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.97
P-value for QMG total score difference	<0.001	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.97
Mean IgG change from baseline (%) with 15 mg/kg maintenance dose	-69.7	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.73
Incidence of treatment-emergent ADA	49.5	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.109
Fremanezumab AUC decrease when co-administered with nipocalimab on same day	66	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.65
CHMP positive opinion date	18 September 2025	Johnson & Johnson — Imaavy EMA EPAR public assessment report, p.9

Source documents

Johnson & Johnson — Imaavy EMA EPAR public assessment report (EMEA/H/C/006379, 2025) (2025)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.