Johnson & Johnson seeks EU nod for nipocalimab to treat antibody-positive myasthenia gravis

Janssen-Cilag International NV, a branch of Johnson & Johnson, recently announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for nipocalimab. This investigational treatment aims to assist individuals with generalised myasthenia gravis (gMG), a chronic, autoimmune disorder.

Nipocalimab works by binding with high affinity and specificity to inhibit the neonatal Fc receptor (FcRn), thereby reducing levels of autoantibodies. This novel approach marks the first submission to the EMA for this particular type of treatment.

The submission includes data from the Phase 3 Vivacity-MG3 study, which assessed the efficacy and safety of nipocalimab in combination with standard care (SOC) compared to a placebo. The study focused on antibody-positive adults, including those with anti-acetylcholine receptor (anti-AChR+), anti-muscle-specific tyrosine kinase (anti-MuSK+), and anti-lipoprotein-related protein 4 (anti-LRP4+) antibodies. These groups represent about 95% of the gMG patient population, making the study significant for demonstrating sustained disease control in these subtypes.

The primary endpoint of the study involved measuring the improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline over 24 weeks. The results showed notable improvement for participants receiving nipocalimab compared to those receiving a placebo. Secondary endpoints included changes in the Quantitative Myasthenia Gravis (QMG) score, a 13-item assessment by clinicians that gauges disease severity.

In the Vivacity-MG3 trial, 199 adult patients with gMG were enrolled, 153 of whom were antibody-positive. The trial was double-blind and placebo-controlled, with participants randomly assigned to receive either nipocalimab plus SOC or a placebo plus SOC. The primary endpoint was the mean change in MG-ADL score over weeks 22, 23, and 24, while secondary endpoints looked at long-term safety and efficacy.

Safety and tolerability of nipocalimab were consistent with previous studies, and the data supports its potential as a long-term treatment option for gMG patients. According to Bill Martin, Ph.D., Global Therapeutic Area Head of Neuroscience at Johnson & Johnson Innovative Medicine, the submission represents a significant step forward in treating autoantibody-driven diseases. He emphasized that providing sustained disease control for gMG patients could substantially enhance their quality of life.

Generalised myasthenia gravis is an autoimmune condition where the immune system mistakenly attacks proteins at the neuromuscular junction. This interference impairs muscle contraction, leading to symptoms such as limb weakness, drooping eyelids, double vision, and difficulties with chewing, swallowing, speech, and breathing. While current standard-of-care treatments manage the condition, there is a pressing need for new therapies that offer better efficacy and tolerability for patients who do not respond well to existing options.

Nipocalimab operates by selectively binding to FcRn, reducing circulating immunoglobulin G (IgG) antibodies without suppressing the broader immune system. This mechanism targets autoantibodies involved in gMG and other conditions, making it a versatile treatment option across several autoantibody-related diseases.

Johnson & Johnson's ongoing commitment to innovation in neuroscience and immunology underscores their dedication to developing new treatments for complex diseases. The company is poised to work closely with the EMA during the review process to bring this promising treatment to market, potentially offering new hope for those affected by gMG.

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