Johnson & Johnson Gains EU Approval for IMAAVY (Nipocalimab) in Generalized Myasthenia Gravis

Johnson & Johnson secured European Commission approval for IMAAVY (nipocalimab), a pioneering FcRn-blocking monoclonal antibody used alongside standard therapy for generalized myasthenia gravis (gMG). This breakthrough covers adults and adolescents aged 12+ positive for anti-AChR or anti-MuSK antibodies, representing over 90% of antibody-positive gMG patients.

By slashing immunoglobulin G levels, a core trigger of muscle weakness, chewing issues, swallowing problems, and speech impairments, the therapy addresses this lifelong autoimmune disorder.

Approval Backed by Phase 3 and Phase 2/3 Trials

The approval draws from both the pivotal Phase 3 Vivacity-MG3 trial and the Phase 2/3 Vibrance-MG study, demonstrating nipocalimab's edge over placebo in disease control at 24 weeks when added to standard care. Vivacity-MG3 highlighted MG-ADL score gains in anti-AChR, anti-MuSK, and anti-LRP4 adults, with open-label extension data showing sustained symptom relief up to 20 months. Safety remained consistent across groups, mirroring placebo in adverse events and dropouts.

Key Adolescent Outcomes from Vibrance-MG

Vibrance-MG focused on anti-AChR-positive teens aged 12-17, delivering deep IgG drops alongside MG-ADL and Quantitative Myasthenia Gravis score improvements at 24 weeks. Most participants hit minimal disease levels, with tolerability matching adult Vivacity-MG3 findings.

Worldwide Rollout Advances for gMG Treatment

Building on existing approvals in the US, Brazil, and Japan, IMAAVY expands FcRn options globally, with more reviews in progress. This targets unmet needs in adolescent gMG care through precise IgG reduction and minimal immune impact.