Nipocalimab Explained

Type:mab
Target:FcRn
Cas Number:2211985-36-1
Pubchem:405226533
Drugbank:DB16257
Kegg:D11666
Unii:87M90CV8NC

Nipocalimab is an experimental high affinity, fully human, aglycosylated, effectorless immunoglobulin G (IgG) anti-FcRn monoclonal antibody.

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.[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 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 Trials

Nipocalimab is in clinical trials in the US

Notes and References

  1. Web site: Drug trial for rare fetal blood disease shows promise for less invasive approach . 30 August 2024 . ScienceDaily . 30 August 2024 . https://web.archive.org/web/20240830133053/https://www.sciencedaily.com/releases/2024/08/240807225457.htm . live .
  2. Web site: 19 August 2020 . J&J Snaps Up Momenta Pharmaceuticals in $6.5 Billion All-Cash Deal . 30 August 2024 . BioSpace . 30 August 2024 . https://web.archive.org/web/20240830130644/https://www.biospace.com/j-and-j-acquires-momenta-pharmaceuticals-and-lead-asset-nipocalimab-for-6-5-billion . live .
  3. Web site: 9 February 2024 . FDA Grants Breakthrough Therapy Designation to Nipocalimab for the Treatment of Rare Disease in Pregnancy . 30 August 2024 . Pharmacy Times . 30 August 2024 . https://web.archive.org/web/20240830130054/https://www.pharmacytimes.com/view/fda-grants-breakthrough-therapy-designation-to-nipocalimab-for-the-treatment-of-rare-disease-in-pregnancy . live .
  4. Web site: Search Orphan Drug Designations and Approvals . U.S. Food and Drug Administration . 30 August 2024 . 30 August 2024 . https://web.archive.org/web/20240830125741/https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=711519 . live .
  5. Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN . 28 July 2020 . 30 August 2024 . Momenta Pharmaceuticals . 30 August 2024 . https://web.archive.org/web/20240830130616/https://www.globenewswire.com/en/news-release/2020/07/28/2068533/0/en/Momenta-Pharmaceuticals-Announces-FDA-Rare-Pediatric-Disease-Designation-for-Nipocalimab-in-HDFN.html . live .
  6. Web site: Johnson & Johnson spotlights nipocalimab at FMF Congress 2024 – the first and only FcRn blocker to be studied in maternal fetal diseases . 30 August 2024 . Janssen . 30 August 2024 . https://web.archive.org/web/20240830131054/https://www.janssen.com/johnson-johnson-spotlights-nipocalimab-fmf-congress-2024-first-and-only-fcrn-blocker-be-studied . live .
  7. 9 February 2024 . 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) . 13 November 2024 . Johnson & Johnson . 8 November 2024 . https://web.archive.org/web/20241108113100/https://www.jnj.com/media-center/press-releases/johnson-johnsons-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 . live .
  8. Web site: Johnson . Johnson & . 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) . 13 November 2024 . www.prnewswire.com . 13 February 2024 . https://web.archive.org/web/20240213041935/https://www.prnewswire.com/news-releases/johnson--johnsons-nipocalimab-granted-us-fda-breakthrough-therapy-designation-for-the-treatment-of-individuals-at-high-risk-for-severe-hemolytic-disease-of-the-fetus-and-newborn-hdfn-302058561.html . live .
  9. Web site: PharmD . Brian Park . 9 February 2024 . Nipocalimab Designated Breakthrough Tx for Hemolytic Disease of the Fetus and Newborn . 13 November 2024 . MPR .
  10. Web site: A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis . 30 August 2024 . clinicaltrials.gov . 30 August 2024 . https://web.archive.org/web/20240830131425/https://clinicaltrials.gov/study/NCT04951622 . live .
  11. Web site: MarketScreener . 30 August 2024 . J&J applies to FDA for nipocalimab - MarketScreener . 30 August 2024 . www.marketscreener.com . 30 August 2024 . https://web.archive.org/web/20240830131947/https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/J-J-applies-to-FDA-for-nipocalimab-47772076/ . live .
  12. Web site: 11 November 2024 . 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 . 13 November 2024 . Johnson & Johnson .
  13. Web site: 13 November 2024 . J&J’s nipocalimab granted FDA breakthrough designation for Sjögren's disease - PMLiVE . 13 November 2024 . pmlive.com .
  14. Web site: A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) . 13 November 2024 . ClinicalTrials.gov.
  15. Web site: A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA) . 30 August 2024 . clinicaltrials.gov . 30 August 2024 . https://web.archive.org/web/20240830131403/https://clinicaltrials.gov/study/NCT05912517 . live .
  16. Web site: A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-1) . 30 August 2024 . clinicaltrials.gov.

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