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Nipocalimab
Nipocalimab is an experimental high affinity, fully human, aglycosylated, effectorless immunoglobulin G (IgG) anti-FcRn monoclonal antibody.[1] For hemolytic disease of the newborn (HDFN), nipocalimab works by decreasing levels of alloantibodies and other circulating IgG antibodies in the mother without impacting immune function. FcRn inhibition is believed to prevent alloantibodies from entering the fetus, which can reduce the risk of HDFN.[2] HistoryNipocalimab was initially developed by Momenta Pharmaceuticals, Inc before it was acquired by Johnson & Johnson in August 2020.[1] Nipocalimab has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of HDFN.[3] Additionally, FDA granted nipocalimab orphan drug designation in HDFN.[4][5] In 2019, nipolcalimab received orphan medicinal product designation by the European Medicines Agency for the treatment of HDFN.[6] In February 2024, nipocalimab was granted breakthrough therapy designation by the US Food and Drug Administration for the treatment of alloimmunized pregnant individuals at high risk of severe HDFN.[7][8][9] In August 2024, Johnson & Johnson applied for FDA approval of nipocalimab for the treatment of people living with generalized myasthenia gravis (gMG). The application is based on data from the phase III Vivacity-MG3 study.[10][11] In November 2024, nipocalimab was granted breakthrough therapy designation by the US Food and Drug Administration as a treatment for adults with moderate-to-severe Sjögren’s disease. The decision was based on the results from the phase II DAHLIAS study evaluating the effects of nipocalimab in more than 160 adults with moderately-to-severely active primary Sjögren’s disease.who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies.[12][13][14] Clinical TrialsNipocalimab is in clinical trials in the US
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