The application is supported by findings from the Phase III Vivacity-MG3 clinical trial.
Assessing the improvement in the MG-ADL score from baseline over 24 weeks was the primary endpoint of the study.
Study participants included adults positive for anti-AChR, anti-MuSK, and anti-LRP4 antibodies, representing approximately 95% of the gMG patient population.
In the trial, nipocalimab, an investigational monoclonal antibody, in combination with standard of care (SOC), produced superior outcomes versus placebo plus SOC in a broad population of antibody-positive subjects with gMG.
The safety and tolerability of nipocalimab were in line with other studies involving the antibody.
The Vivacity-MG3 trial is claimed to be the first and only study to show sustained disease control across these subtypes.
A FcRn blocker, nipocalimab demonstrated lasting disease control, as measured by improvements in MG-ADL, when added to SOC compared to placebo plus SOC over a six-month period of consistent bi-weekly dosing.
Johnson & Johnson Innovative Medicine Neuroscience Global Therapeutic Area head Bill Martin said: “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.
“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. We look forward to working with the FDA in their review of the data supporting the submission.”