Nipocalimab

Johnson & Johnson's phase 2/3 Vibrance-MG study shows nipocalimab plus standard of care (SOC) effectively controls generalized myasthenia gravis (gMG) in adolescents, with significant IgG reduction and clinical benefits. The study's positive results will be presented at the MGFA Scientific Session. Nipocalimab's potential as a treatment for adolescents with gMG is highlighted, as there are currently no approved advanced treatments for this population in the U.S.

Johnson & Johnson's nipocalimab showed sustained disease control in adolescents with generalized myasthenia gravis, with 70% reduction in IgG and no serious AEs, suggesting a promising treatment option for this age group.

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Johnson & Johnson announces positive Phase 2/3 Vibrance-MG study results for nipocalimab in anti-AChR positive adolescents (12-17) with generalized myasthenia gravis, showing sustained disease control over 24 weeks with significant IgG reduction and improvement in MG-ADL and QMG scores.

Nipocalimab shows sustained disease control in adolescents with generalized myasthenia gravis (gMG) in Phase 2/3 study, achieving significant IgG reduction and improvement in MG-ADL and QMG scores.

Johnson & Johnson's Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRa positive adolescents with gMG showed sustained disease control, with 4/5 patients achieving minimum symptom expression. Nipocalimab was well-tolerated, with no serious adverse events. Applications for approval were submitted to the FDA and EMA.

Johnson & Johnson's Phase 2/3 Vibrance-MG study of nipocalimab in adolescents with generalized myasthenia gravis met primary and secondary endpoints, showing sustained disease control over 24 weeks with no serious adverse events.

Positive Phase 2/3 Vibrance-MG study results show nipocalimab plus standard of care (SOC) achieved sustained disease control in anti-AChR positive adolescents (12-17 years) with generalized myasthenia gravis (gMG), with significant IgG reduction and improvement in MG-ADL and QMG scores over 24 weeks.

Johnson & Johnson submitted a Biologics License Application to the FDA for nipocalimab, seeking approval for treating generalized myasthenia gravis (gMG). The Phase 3 Vivacity-MG3 study showed superior outcomes for antibody-positive participants receiving nipocalimab plus standard of care compared to placebo plus SOC. Nipocalimab is the first FcRn blocker to demonstrate sustained disease control over six months, with consistent safety and tolerability.