Johnson & Johnson’s nipocalimab shows disease control in myasthenia gravis

Johnson & Johnson announced positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRa positive adolescents living with generalized myasthenia gravis or gMG. Study participants who were treated with nipocalimab plus standard of care achieved sustained disease control as measured by the primary endpoint of immunoglobulin G reduction from baseline over 24 weeks, and secondary endpoints of improvement in MG-ADLb and QMGc scores. There are currently no approved advanced treatment options for this adolescent population in the U.S. Four of five patients achieved minimum symptom expression by the end of their treatment phase. Nipocalimab was well-tolerated over the six-month period, similar to tolerability seen in adult participants in the Vivacity-MG3 study. There were no serious adverse events and no discontinuations due to an adverse event. Earlier this year, Johnson & Johnson announced the submission of applications to the FDA and the EMA seeking approval for nipocalimab for the treatment of gMG.