Johnson & Johnson has received European Commission approval for nipocalimab, marketed as IMAAVY, as an add-on therapy for generalised myasthenia gravis (gMG).
The decision makes nipocalimab the first FcRn blocker authorised for both adults and adolescents aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody-positive.
gMG is a chronic autoimmune condition that causes muscle weakness and difficulties with chewing, swallowing and speaking. Anti-AChR and anti-MuSK antibody-positive individuals account for around 90% of the gMG population. Nipocalimab works by selectively reducing immunoglobulin G, a root cause of the disease, while leaving other immune functions unaffected.
Professor Andreas Meisel, Charité – Universitätsmedizin Berlin, said: “With today’s approval of nipocalimab, we now have an important new treatment option for a broad range of antibody-positive people living with generalised myasthenia gravis (gMG). This decision reflects a major advance in therapeutic approaches designed to enhance symptom control and the long-term management of gMG both in adolescents and adults.”
The European Myasthenia Gravis Association board said: “Myasthenia gravis is an invisible disease, but its impact is anything but. It touches every part of our lives: our independence, education, careers, social life and mental health. Too often, our struggles go unseen and misunderstood. We need greater awareness, better resources, and stronger support systems so that people living with generalised myasthenia gravis can lead the lives they deserve.”
Clinical evidence from the pivotal phase 3 Vivacity-MG3 study showed patients receiving nipocalimab plus standard care achieved superior disease control compared to placebo. Improvements were maintained for up to 20 months in the open-label extension. Safety and tolerability were consistent with previous studies.
Professor Francesco Saccà, University Federico II of Naples, explained: “Even with advances in treatment, people living with generalised myasthenia gravis continue to experience unpredictable symptom fluctuations that can disrupt daily life. With strong data from the Vivacity-MG3 and Vibrance-MG studies, nipocalimab provides an important new option that could help achieve sustained disease control and support greater stability for patients managing this challenging condition.”
Mark Graham, Senior Director, Johnson & Johnson Innovative Medicine EMEA, said: “An estimated 56,000 to 123,000 people across Europe live with generalised myasthenia gravis (gMG), a condition that can make even simple activities like breathing or walking a daily challenge.
The approval of nipocalimab as the first FcRn blocker to treat a broad population of adults and adolescents living with gMG marks a meaningful advance in addressing persisting unmet needs and supporting more consistent, long-term disease management for patients.”
