Nipocalimab

Last updated

Nipocalimab
Monoclonal antibody
Type Whole antibody
Source Human
Target FcRn
Clinical data
Trade names Imaavy
Other namesnipocalimab-aahu
License data
Routes of
administration 		Intravenous infusion
ATC code
  • None
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

Nipocalimab, sold under the brand name Imaavy, is a monoclonal antibody used for the treatment of generalized myasthenia gravis. [1] It is a neonatal Fc receptor blocker. [1] It is an high affinity, fully human, aglycosylated, effectorless immunoglobulin G (IgG) anti-FcRn monoclonal antibody. [2] [3]

Contents

Nipocalimab was approved for medical use in the United States in April 2025. [4] [5]

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 U.S. Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn. [6] Additionally, the FDA granted nipocalimab orphan drug designation in hemolytic disease of the fetus and newborn. [7] [8] In 2019, nipocalimab received orphan medicinal product designation by the European Medicines Agency for the treatment of HDFN. [9]

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. [10] [11] [12]

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. [13] [14]

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. [15] [16] [17]

Society and culture

Nipocalimab was approved for medical use in the United States in April 2025. [1] [5]

Names

Nipocalimab is the international nonproprietary name. [18]

Nipocalimab is sold under the brand name Imaavy. [1] [5]

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. [19]

Clinical Trials

Nipocalimab is in clinical trials in the US

References

  1. 1 2 3 4 5 6 fda.gov
  2. 1 2 "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.
  3. ↑ 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.
  4. ↑ "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.
  5. 1 2 3 "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. Retrieved 1 May 2025– via MultiVu.
  6. ↑ "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.
  7. ↑ "Search Orphan Drug Designations and Approvals". U.S. Food and Drug Administration. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  8. ↑ "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.
  9. ↑ "Johnson & Johnson spotlights nipocalimab at FMF Congress 2024 – the first and only FcRn blocker to be studied in maternal fetal diseases". Janssen. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  10. ↑ "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.
  11. ↑ 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.
  12. ↑ PharmD BP (9 February 2024). "Nipocalimab Designated Breakthrough Tx for Hemolytic Disease of the Fetus and Newborn". MPR. Retrieved 13 November 2024.
  13. ↑ "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.
  14. ↑ MarketScreener (30 August 2024). "J&J applies to FDA for nipocalimab - MarketScreener". www.marketscreener.com. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  15. ↑ "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. 11 November 2024. Retrieved 13 November 2024.
  16. ↑ "J&J's nipocalimab granted FDA breakthrough designation for Sjögren's disease". PMLiVE. 13 November 2024. Retrieved 13 November 2024.
  17. ↑ "A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)". ClinicalTrials.gov. Retrieved 13 November 2024.
  18. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl: 10665/340680 .
  19. ↑ "Drug trial for rare fetal blood disease shows promise for less invasive approach". ScienceDaily. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  20. ↑ "A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA)". clinicaltrials.gov. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  21. ↑ "A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-1)". clinicaltrials.gov. Retrieved 30 August 2024.
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