Nipocalimab is the first FcRn blocker approved in both adult and adolescent gMG patients aged 12 and older who are anti-AChR or anti-MuSK antibody-positive
Johnson & Johnson announced that the European Commission has approved a Marketing Authorisation for IMAAVY (nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). gMG is a chronic, incurable autoantibody disease that causes debilitating symptoms such as muscle weakness, difficulty chewing, swallowing and speaking. This approval is for the treatment of a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody-positive.
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Anti-AChR and anti-MuSK antibody-positive individuals comprise ≥90% of the total antibody-positive gMG population. Nipocalimab is an immunoselective therapy designed to substantially reduce immunoglobulin G (IgG), a root cause of gMG, without additional detectable effects on other adaptive and innate immune functions.
“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),” said Professor Andreas Meisel, Charité – Universitätsmedizin Berlin. “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.”
“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,” said the European Myasthenia Gravis Association (EuMGA) board. “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.”
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This approval is supported by the data from the pivotal, ongoing Phase 3 Vivacity-MG3 study which showed patients who received nipocalimab plus standard of care (SOC) had superior disease control compared to those who received placebo plus SOC throughout 24 weeks. The primary endpoint of the study measured improvement in the MG-ADL score from baseline over 24 weeks across study participants which included anti-AChR, anti-MuSK, and anti-low density lipoprotein-related protein 4 [LRP4] antibody-positive adults. Patients who entered the open-label extension (OLE) phase of Vivacity-MG3 and continued their treatment with nipocalimab maintained improvements for up to 20 months of follow-up and demonstrated sustained disease control over this long duration. Safety and tolerability were consistent with other nipocalimab studies. The overall incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to discontinuation were similar to that in the placebo plus SOC group.
“Even with advances in treatment, people living with generalised myasthenia gravis continue to experience unpredictable symptom fluctuations that can disrupt daily life,” said Professor Francesco Saccà, University Federico II of Naples. “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.”
This approval also includes data from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChR antibody-positive adolescents (aged 12–17 years) living with gMG. Study participants who were treated with nipocalimab plus SOC achieved sustained disease control as measured by the primary endpoint of IgG reduction from baseline over 24 weeks compared to placebo plus SOC, and secondary endpoints of improvement in MG-ADL and QMG scores. Nipocalimab was well-tolerated over the six-month period, with tolerability similar to that seen in adult participants in the Vivacity-MG3 study.
“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,” said Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “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.”
Nipocalimab is already approved in the U.S., Brazil and Japan for the treatment of gMG, with further health authority submissions currently under review worldwide.
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Source- GlobeNewswire
