Nipocalimab is a human IgG1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), thereby decreasing the levels of circulating IgG, including pathogenic IgG autoantibodies.[4]
Nipocalimab was approved for medical use in the United States in April 2025.[5][6]
Medical uses
Nipocalimab is indicated for the treatment of generalized myasthenia gravis in people aged twelve years of age and older who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.[1]
History
Nipocalimab was initially developed by Momenta Pharmaceuticals, Inc before it was acquired by Johnson & Johnson in August 2020.[2]
Nipocalimab has received rare pediatric disease designation from the US Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn.[7] Additionally, the FDA granted nipocalimab orphan drug designation in hemolytic disease of the fetus and newborn.[8][9] In 2019, nipocalimab received orphan medicinal product designation by the European Medicines Agency for the treatment of HDFN.[10]
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 hemolytic disease of the fetus and newborn.[11][12][13]
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.[14][15]
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.[16][17][18]
Society and culture
Legal status
Nipocalimab was approved for medical use in the United States in April 2025.[1][6]
In September 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imaavy, intended for the treatment of generalized myasthenia gravis.[4] The applicant for this medicinal product is Janssen-Cilag International NV.[4]
Nipocalimab is sold under the brand name Imaavy.[1][6]
Research
For hemolytic disease of the newborn, 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 hemolytic disease of the newborn.[20]
1 2 3 "Imaavy EPAR". European Medicines Agency (EMA). 19 September 2025. Retrieved 27 September 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
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