European Commission Greenlights Nipocalimab for Generalized Myasthenia Gravis

IMAAVY (nipocalimab) has received European Commission approval as an add‑on to standard therapy for generalized myasthenia gravis (gMG) in adults and adolescents aged 12 years and older who are anti‑AChR or anti‑MuSK antibody‑positive.

FcRn blockade inhibits the neonatal Fc receptor, preventing IgG recycling and rapidly lowering circulating IgG concentrations. By reducing pathogenic IgG at the neuromuscular junction, this mechanism directly targets the proximal driver of fatigable weakness in antibody‑positive gMG and produces predictable pharmacodynamic effects.

In pivotal randomized trials, nipocalimab produced clinically meaningful efficacy with a consistent tolerability profile in adult and adolescent gMG populations.

Availability of nipocalimab will broaden options for adolescents and adults with antibody‑positive gMG; accumulating real‑world evidence will clarify long‑term safety, durability of response, and comparative positioning versus other immunotherapies.