Johnson & Johnson has submitted a Biologics License Application to the US Food and Drug Administration (FDA) for nipocalimab.
This marks the company’s first application for the approval of the therapeutic in patients with generalised myasthenia gravis (gMG) — a chronic autoimmune disease which causes the body to attack voluntary muscles in the body.
Nipocalimab is the first and only FcRn blocker that has been able to exhibit and sustained disease control, according to the pharmaceutical company.
The approval request incorporated data from the Phase III Vivacity-MG3 study, which highlighted the positive impacts of the drug as an adjuvant to the current standard of care regimen compared to placebo.
During the 24 week study period, nipocalimab exhibited sustained disease control in anti-AChR+, anti-MuSK+ and anti-LRP4+ subtypes, which Johnson & Johnson claims is the first study to demonstrate this effect in these patient sectors.
The safety and tolerability of nipocalimab was also consistent with previous studies in the Phase III trial.
"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," said Bill Martin, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine.
"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, building on decades of expertise in neuroscience and immunology."