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Nipocalimab

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Nipocalimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetFcRn
Clinical data
Trade namesImaavy
Other namesJNJ-80202135, M281, nipocalimab-aahu
AHFS/Drugs.comMonograph
MedlinePlusa625078
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
FormulaC6266H9722N1670O1992S46
Molar mass141797.16 g·mol−1

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]

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

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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

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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

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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

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Nipocalimab is the international nonproprietary name.[24][25]

Nipocalimab is sold under the brand name Imaavy.[6][23]

References

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  1. ↑ "Imaavy Product information". Health Canada. 5 December 2025. Retrieved 2 January 2026.
  2. ↑ "Imaavy Product information". Health Canada. 23 January 2026. Retrieved 29 August 2026.
  3. 1 2 "Summary Basis of Decision for Imaavy". Dhpp.hpfb-dgpsa.ca. Retrieved 14 July 2026.
  4. 1 2 3 4 5 "Imaavy- nipocalimab injection, solution, concentrate". DailyMed. 6 May 2025. Retrieved 24 June 2025.
  5. 1 2 3 4 5 6 7 "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.
  6. 1 2 3 "Imaavy Product information". Union Register of medicinal products. 1 December 2025. Retrieved 17 February 2026.
  7. ↑ Seth NP, Xu R, DuPrie M, Choudhury A, Sihapong S, Tyler S, et al. (December 2025). "Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties". mAbs. 17 (1) 2461191. doi:10.1080/19420862.2025.2461191. PMC 11834464. PMID 39936406.
  8. 1 2 3 4 5 6 7 8 9 10 11 "FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia". U.S. Food and Drug Administration (FDA). 25 August 2026. Retrieved 29 August 2026. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ↑ "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). 1 May 2025. Archived from the original on 3 March 2025. Retrieved 1 May 2025.
  10. ↑ "J&J Snaps Up Momenta Pharmaceuticals in $6.5 Billion All-Cash Deal". BioSpace. 19 August 2020. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  11. ↑ "FDA Grants Breakthrough Therapy Designation to Nipocalimab for the Treatment of Rare Disease in Pregnancy". Pharmacy Times. 9 February 2024. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  12. ↑ "Search Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  13. ↑ "Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN". Momenta Pharmaceuticals (Press release). 28 July 2020. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  14. ↑ "Johnson & Johnson spotlights nipocalimab at FMF Congress 2024 – the first and only FcRn blocker to be studied in maternal fetal diseases". Janssen (Press release). Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  15. ↑ "Johnson & Johnson's nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)". Johnson & Johnson (Press release). 9 February 2024. Archived from the original on 8 November 2024. Retrieved 13 November 2024.
  16. ↑ Johnson J&. "Johnson & Johnson's nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)". www.prnewswire.com (Press release). Archived from the original on 13 February 2024. Retrieved 13 November 2024.
  17. ↑ Park B (9 February 2024). "Nipocalimab Designated Breakthrough Tx for Hemolytic Disease of the Fetus and Newborn". MPR (Press release). Retrieved 13 November 2024.
  18. ↑ "A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis". clinicaltrials.gov. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  19. ↑ "J&J applies to FDA for nipocalimab". MarketScreener (Press release). 30 August 2024. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  20. ↑ "Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease". Johnson & Johnson (Press release). 11 November 2024. Retrieved 13 November 2024.
  21. ↑ "J&J's nipocalimab granted FDA breakthrough designation for Sjögren's disease". PMLiVE (Press release). 13 November 2024. Retrieved 13 November 2024.
  22. ↑ "A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)". ClinicalTrials.gov. Retrieved 13 November 2024.
  23. 1 2 "Johnson & Johnson receives FDA approval for Imaavy (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)" (Press release). Johnson & Johnson. 30 April 2025. Archived from the original on 1 May 2025. Retrieved 1 May 2025 – via MultiVu.
  24. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
  25. ↑ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 91". WHO Drug Information. 38 (1). hdl:10665/378096.
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