Johnson & Johnson Secures European Commission Approval for IMAAVY (Nipocalimab) to Treat Generalised Myasthenia Gravis

The European Commission has granted Marketing Authorisation to Johnson & Johnson for IMAAVY (nipocalimab), a novel FcRn-blocking antibody therapy designed to help people living with generalised myasthenia gravis (gMG). The approval covers both adult and adolescent patients aged 12 years and older who test positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies.

gMG is a chronic autoimmune neuromuscular disorder that impairs communication between nerves and muscles, leading to weakness, fatigue, and difficulties with speaking, chewing, and swallowing. With limited treatment options available, nipocalimab introduces a new mechanism aimed at addressing one of the root causes of the disease.

Expanding gMG Treatment Options in Europe

Nipocalimab is a fully human monoclonal antibody that selectively blocks the neonatal Fc receptor (FcRn), leading to a targeted reduction in immunoglobulin G (IgG) without broadly suppressing the immune system. By lowering IgG levels, the therapy reduces pathogenic autoantibodies associated with gMG while preserving other key immune functions.

Trials supporting the approval

The approval is supported by results from the Phase 3 Vivacity-MG3 and Phase 2/3 Vibrance-MG clinical studies. In Vivacity-MG3, patients receiving nipocalimab alongside standard therapy experienced notable improvements in disease control compared to those on placebo plus standard of care over a 24-week period. Participants who continued into the open-label extension maintained symptom relief and functional improvements for up to 20 months.

Demonstrated Efficacy Across Adult and Adolescent Populations

The adolescent-focused Vibrance-MG study further reinforced nipocalimab’s potential, with patients aged 12 to 17 achieving sustained reductions in IgG and improvements in disease activity measures. Across both trials, nipocalimab demonstrated a favorable safety and tolerability profile, with adverse events comparable to placebo treatment.

Global Regulatory Momentum

With this European authorisation, nipocalimab becomes the first FcRn blocker approved for both adult and adolescent patients with gMG who are anti-AChR or anti-MuSK antibody-positive.

The medicine has already received approval in the United States, Brazil, and Japan, and additional regulatory submissions remain under review worldwide.