Johnson & Johnson — Imaavy EMA EPAR public assessment report (EMEA/H/C/006379, 2025)
Johnson & Johnson · 2025 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Johnson & Johnson's Imaavy (nipocalimab) for generalized Myasthenia Gravis (gMG) resulted in a positive CHMP opinion for marketing authorization for antibody-positive adult and adolescent patients (12+). The report details nipocalimab's manufacturing, quality control, and non-clinical safety, including its mechanism of action and tolerability in cynomolgus monkeys. Clinical studies demonstrated statistically significant improvements in MG-ADL and QMG scores compared to placebo. While effective, safety concerns include infections, lipid changes, decreased albumin, and cardiovascular risks, necessitating long-term monitoring and a robust Risk Management Plan. The indication is restricted to anti-AChR or anti-MuSK antibody positive patients.
Key findings — cited to the page
| Headache (IRR) | 3 | · p.146 |
| Headache (IRR) | 7 | · p.146 |
| Participants experiencing AECI of IRR | 13 | · p.146 |
| Nipocalimab vial presentation 2 | 1200 mg | Imaavy (nipocalimab) · p.11 |
| Nipocalimab concentration | 185 mg/mL | Imaavy (nipocalimab) · p.11 |
| Nipocalimab vial presentation 1 | 300 mg | Imaavy (nipocalimab) · p.11 |
| Nipocalimab initial dose | 30 mg/kg | Imaavy (nipocalimab) · p.11 |
| Proposed indication for nipocalimab | 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 antibody positive (anti- acetylcholine receptor [AChR], anti- muscle-specific tyrosine kinase [MuSK], or anti-low-density lipoprotein receptor 4 [LRP4]) | Imaavy (nipocalimab) · p.7 |
| CHMP revised opinion adoption date | 3 November 2025 | Imaavy (nipocalimab) · p.9 |
| Final agreed indication for nipocalimab | 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 | Imaavy (nipocalimab) · p.11 |
| Nipocalimab maintenance dosing frequency | every 2 weeks | Imaavy (nipocalimab) · p.11 |
| Application submission date | 13 September 2024 | Imaavy (nipocalimab) · Europe · p.7 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →