Nipocalimab
Chemical compound
From Wikipedia, the free encyclopedia
Nipocalimab, sold under the brand name Imaavy, is a monoclonal antibody used for the treatment of generalized myasthenia gravis or warm autoimmune hemolytic anemia.[4] It is a neonatal Fc receptor blocker.[4] It is a high affinity, fully human, aglycosylated, effectorless immunoglobulin G (IgG) anti-FcRn monoclonal antibody.[7] 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.[5]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | FcRn |
| Clinical data | |
| Trade names | Imaavy |
| Other names | JNJ-80202135, M281, nipocalimab-aahu |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625078 |
| License data |
|
| Routes of administration | Intravenous infusion |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem CID | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6266H9722N1670O1992S46 |
| Molar mass | 141797.16 g·mol−1 |
The most common adverse reactions in people with warm autoimmune hemolytic anemia include peripheral edema (swelling of the lower legs, ankles, feet caused by a build-up of fluid in body tissues), diarrhea and fever.[8] Other side effects are infusion-related reactions, including headache, fatigue, influenza-like illness, rash, nausea, dizziness, chills, and erythema (redness of the skin).[8]
Nipocalimab was approved for medical use in the United States in April 2025,[9] in the European Union in November 2025,[5] and in Canada in January 2026.[3]
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;[4][5] or for the treatment of warm autoimmune hemolytic anemia in people aged twelve years of age and older currently or previously treated with corticosteroids.[4][8]
Warm autoimmune hemolytic anemia is a rare blood disorder where the immune system mistakenly attacks and destroys the body's own red blood cells — a process called hemolysis.[8] This destruction happens faster than the body can replace the red blood cells, leading to a shortage of healthy red blood cells (anemia).[8]
History
Nipocalimab was developed by Momenta Pharmaceuticals before it was acquired by Johnson & Johnson in August 2020.[10]
Nipocalimab received rare pediatric disease designation from the US Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn.[11] Additionally, the FDA granted nipocalimab orphan drug designation in hemolytic disease of the fetus and newborn.[12][13] In 2019, nipocalimab received orphan medicinal product designation by the European Medicines Agency for the treatment of HDFN.[14]
In February 2024, nipocalimab was granted breakthrough therapy designation by the FDA for the treatment of alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn.[15][16][17]
In August 2024, Johnson & Johnson applied for FDA approval of nipocalimab for the treatment of people living with generalized myasthenia gravis. The application is based on data from the phase III Vivacity-MG3 study.[18][19]
In November 2024, nipocalimab was granted breakthrough therapy designation by the FDA 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.[20][21][22]
In August 2026, the FDA approved nipocalimab for the treatment of warm autoimmune hemolytic anemia in people aged twelve years of age and older currently or previously treated with corticosteroids.[8] The FDA based its approval on results from the wAIHA Study (NCT04119050), a 24-week, randomized, double-blind, placebo-controlled clinical trial.[8] The study enrolled participants with a confirmed wAIHA diagnosis of at least three months who had low hemoglobin levels (below 10 g/dL), evidence of active red blood cell destruction (hemolysis), and a positive direct antiglobulin test (DAT) - a blood test that detects antibodies attacking red blood cells.[8] All participants had previously received or were currently receiving treatment for warm autoimmune hemolytic anemia, reflecting a population with a significant unmet medical need.[8] The FDA granted the application for nipocalimab fast track, priority review, and orphan drug designations for this indication.[8] The FDA granted approval of Imaavy to Janssen Biotech.[8]
Society and culture
Legal status
Nipocalimab was approved for medical use in the United States in April 2025.[23]
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.[5] The applicant for this medicinal product is Janssen-Cilag International NV.[5] Nipocalimab was authorized for medical use in the European Union in November 2025.[5][6]
Names
Nipocalimab is the international nonproprietary name.[24][25]
