Nipocalimab

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.

Johnson & Johnson submits a Biologics License Application to the FDA seeking the first approval of nipocalimab globally for treating generalized myasthenia gravis (gMG). The application included data from the Phase 3 Vivacity-MG3 study showing superior outcomes for antibody positive participants who received nipocalimab plus standard of care compared to placebo plus standard of care. Nipocalimab is the first-and-only FcRn blocker to demonstrate sustained disease control in gMG.