Nipocalimab

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.

Johnson & Johnson seeks EMA approval for nipocalimab to treat generalized myasthenia gravis (gMG) in patients with MG-causing autoantibodies. Based on Phase 3 Vivacity-MG3 trial data, nipocalimab plus standard care significantly eased disease severity. The therapy aims to accelerate degradation of MG-driving antibodies by blocking FcRn activity, similar to Rystiggo and Vyvgart. Nipocalimab also demonstrated sustained disease control over six months.

Janssen-Cilag International NV submitted an MAA to the EMA for nipocalimab, seeking approval for treating generalized myasthenia gravis (gMG). The phase 3 Vivacity-MG3 study showed nipocalimab plus standard of care (SOC) outperformed placebo plus SOC in improving MG-ADL scores. Nipocalimab is the first FcRn blocker to demonstrate sustained disease control in gMG subtypes, with safety and tolerability consistent with previous studies.

Janssen-Cilag International NV submits MAA to EMA for nipocalimab, an FcRn blocker, based on Phase 3 Vivacity-MG3 study results showing sustained disease control in antibody-positive gMG patients over 24 weeks.

Janssen-Cilag International NV, a Johnson & Johnson company, submitted a Marketing Authorisation Application to the European Medicines Agency for nipocalimab, seeking its first approval for treating generalised myasthenia gravis, based on Phase 3 Vivacity-MG3 study data.

Janssen-Cilag International NV submitted an MAA to the EMA for nipocalimab, seeking approval for treating generalized myasthenia gravis (gMG). Bill Martin, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, expressed optimism about nipocalimab's potential to control gMG, highlighting the company's commitment to innovative treatments for autoantibody-driven diseases.

Janssen-Cilag International NV submits MAA to EMA for nipocalimab, an FcRn blocker, based on Phase 3 Vivacity-MG3 study showing sustained disease control in antibody-positive gMG patients over 24 weeks.

Janssen-Cilag submits MAA to EMA for nipocalimab, an FcRn blocker for gMG, based on Phase 3 Vivacity-MG3 study results showing sustained disease control in antibody-positive patients over 24 weeks.

Johnson & Johnson (J&J) has submitted nipocalimab, an FcRn blocker, for FDA approval for generalized myasthenia gravis, with potential to treat up to 10 disease indications, including rheumatoid arthritis.

Johnson & Johnson submitted a BLA to the FDA for nipocalimab, an investigational therapy for generalized myasthenia gravis (gMG), based on data from the Phase III Vivacity-MG3 trial. Nipocalimab, an FcRn blocker, showed sustained disease control in gMG patients over 24 weeks, marking the longest controlled safety and efficacy assessment in this patient group.