Nipocalimab

J&J aims to address generalized myasthenia gravis using nipocalimab, as reported by Pharmaceutical Technology. The article emphasizes seeking professional advice before making decisions based on its content.

Johnson & Johnson submitted a BLA to the FDA for nipocalimab, an FcRn blocker for gMG, supported by phase III Vivacity-MG3 study data showing sustained disease control. Nipocalimab faces competition from Argenx’s and UCB’s FcRn blockers. J&J is also testing nipocalimab in other conditions, holding a Zacks Rank #4.

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.

Johnson & Johnson seeks FDA approval for nipocalimab, a drug targeting generalized myasthenia gravis by reducing harmful antibodies. Proven effective in a Phase 3 study, it aims to set a new standard in treating autoantibody-driven diseases, with potential applications in rheumatoid arthritis and other conditions.

Johnson & Johnson announces the publication of positive Phase 2 UNITY study results of nipocalimab in The New England Journal of Medicine for treating alloimmunized pregnant individuals at risk of early onset severe hemolytic disease of the fetus and newborn (HDFN), showing 54% achieved live birth at or after 32 weeks gestational age without intrauterine transfusion (IUT), suggesting nipocalimab could be the first non-surgical treatment for high-risk HDFN pregnancies.