Nipocalimab up for approval for gMG in the European Union
Phase 3 trial showed treatment helped ease disease severity
Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) seeking approval of nipocalimab to treat people with generalized myasthenia gravis (gMG).
The request includes gMG patients who are positive for MG-causing autoantibodies targeting acetylcholine receptors (AChRs), muscle-specific tyrosine (MuSK), and low-density lipoprotein receptor-related protein 4 (LRP4), which together encompass about 95% of all gMG cases.
The submission was based on data from the Phase 3 Vivacity-MG3 trial (NCT04951622) which showed that, when compared to a placebo, nipocalimab plus standard of care therapy significantly eased disease severity in gMG patients. The company is also seeking U.S. approval of the therapy as a gMG treatment.
“We are encouraged by the potential of nipocalimab to provide sustained disease control for people living with generalized myasthenia gravis, a chronic, life-long disease,” Bill Martin, PhD, global therapeutic area head of neuroscience at Johnson & Johnson Innovative Medicine, said in a company press release. “We look forward to working with the EMA in their review of the data supporting the submission.”
MG is an autoimmune disorder triggered by immunoglobulin G (IgG) antibodies erroneously targeting proteins essential for effective nerve-muscle communication, including AChR, MuSK, and LRP4.
Antibody-based therapy
Nipocalimab is an antibody-based therapy designed to block the activity of the neonatal Fc receptor (FcRn), a protein that helps prevent IgGs circulating in the bloodstream from being degraded. The treatment is expected to accelerate the degradation of MG-driving antibodies, lowering their levels in the bloodstream and easing gMG symptoms. It belongs to the same class of therapies that include Rystiggo (rozanolixizumab-noli) and Vyvgart (efgartigimod alfa), two treatments approved for people with gMG.
The Vivacity-MG3 trial is evaluating nipocalimab’s safety and efficacy in 199 adults with gMG, most of whom had antibodies against AChRs, MuSK, and/or LRP4, and who had insufficient response to standard-of-care treatments. In addition to standard care, participants were randomly assigned to receive intravenous (into-the-vein) infusions of nipocalimab, at an initial loading dose of 30 mg/kg followed by 15 mg/kg once every two weeks, or a placebo for about six months.
Patients receiving nipocalimab experienced a significant reduction in MG severity, as measured by the MG Activities of Daily Living (MG-ADL) scale. The average decrease in MG-ADL scores from the beginning of the study to the final three weeks of treatment was 4.7 points in the nipocalimab group, compared with a 3.25-point reduction in the placebo group.
Secondary measures of efficacy were also met, including a significant improvement in muscle strength and function after 22-24 weeks.
Nipocalimab’s safety and tolerability were similar to what has been observed in other trials. The overall incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation were similar in nipocalimab- and placebo-treated patients.
According to the company, nipocalimab is the first FcRn blocker demonstrating sustained disease control when added to standard of care over six months of consistent dosing.
“The filing for approval of nipocalimab represents an important step forward as Johnson & Johnson continues to push the boundaries of research to develop innovative solutions to treat autoantibody-driven diseases,” Martin said.
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