Wedoany.com Report-Dec.5, The European Commission has granted marketing authorisation for nipocalimab (IMAAVY™), developed by Johnson & Johnson, as an add-on treatment for generalised myasthenia gravis (gMG) in patients aged 12 years and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody-positive.

Nipocalimab is the first neonatal Fc receptor (FcRn) blocker approved in Europe for both adults and adolescents within this antibody-positive gMG population, which represents approximately 90% of all gMG cases. The therapy selectively lowers pathogenic immunoglobulin G levels while preserving broader immune system function.

Professor Andreas Meisel from Charité – Universitätsmedizin Berlin commented: "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 stated: "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."

Approval was supported by results from the Phase 3 Vivacity-MG3 study, in which nipocalimab combined with standard of care demonstrated significantly greater disease control versus placebo plus standard of care. Benefits were sustained for up to 20 months in the open-label extension phase. The safety profile remained consistent with earlier clinical trials.

Professor Francesco Saccà of the University Federico II of Naples noted: "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 at Johnson & Johnson Innovative Medicine EMEA, added: "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."

With this authorisation, nipocalimab becomes available as a new therapeutic choice for eligible European patients with antibody-positive generalised myasthenia gravis.