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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.

History

Nipocalimab was initially developed by Momenta Pharmaceuticals, Inc before it was acquired by Johnson & Johnson in August 2020.

Nipocalimab has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of HDFN. Additionally, FDA granted nipocalimab orphan drug designation in HDFN. In 2019, nipolcalimab received orphan medicinal product designation by the European Medicines Agency for the treatment of HDFN.

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.

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.

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.

Clinical Trials

Nipocalimab is in clinical trials in the US

• The AZALEA pivotal phase III trial focuses on pregnant individuals who are at risk of a severe HDFN pregnancy
• The FREESIA pivotal phase III trial focuses on patients who are at risk of an FNAIT pregnancy

References

1. ^ "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.
2. "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.
3. "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.
4. "Search Orphan Drug Designations and Approvals". U.S. Food and Drug Administration. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
5. "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.
6. "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.
7. "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.
8. 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. Archived from the original on 13 February 2024. Retrieved 13 November 2024.
9. PharmD BP (9 February 2024). "Nipocalimab Designated Breakthrough Tx for Hemolytic Disease of the Fetus and Newborn". MPR. Retrieved 13 November 2024.
10. "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.
11. 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.
12. "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.
13. "J&J's nipocalimab granted FDA breakthrough designation for Sjögren's disease - PMLiVE". pmlive.com. 13 November 2024. Retrieved 13 November 2024.
14. "A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)". ClinicalTrials.gov. Retrieved 13 November 2024.
15. "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.
16. "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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