- IMAAVY® (nipocalimab) is approved for treating generalised myasthenia gravis (gMG) in the EU.
- The approval covers adults and adolescents aged 12 and older with specific antibody profiles.
- Phase 3 Vivacity-MG3 study showed superior disease control with nipocalimab plus standard care.
- Nipocalimab is already approved in the U.S., Brazil, and Japan for gMG treatment.
Approval Overview
The European Commission has approved IMAAVY® (nipocalimab), a fully human FcRn-blocking monoclonal antibody, for treating generalised myasthenia gravis (gMG) as an add-on to standard therapy. This approval applies to adults and adolescents aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody-positive.
Clinical Study Insights
The approval is based on data from the Phase 3 Vivacity-MG3 study, which demonstrated that patients receiving nipocalimab plus standard of care (SOC) had superior disease control compared to those on placebo plus SOC over 24 weeks. The study included participants with anti-AChR, anti-MuSK, and anti-low density lipoprotein-related protein 4 (LRP4) antibody-positive adults. Patients in the open-label extension phase maintained improvements for up to 20 months.
Safety and Tolerability
Nipocalimab showed consistent safety and tolerability, with adverse events similar to those in the placebo group. The Phase 2/3 Vibrance-MG study in adolescents also supported these findings, showing sustained disease control and well-tolerated treatment over six months.
Global Context
Nipocalimab is already approved for gMG treatment in the U.S., Brazil, and Japan, with further submissions under review worldwide. The approval marks a significant step in addressing unmet needs and supporting long-term disease management for gMG patients.
