Nipocalimab
| Monoclonal antibody | |
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| Type | ? |
| Target | FcRn |
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Nipocalimab is a high affinity, fully human, aglycosylated, effectorless immunoglobulin G (IgG) anti-FcRn monoclonal antibody.[1]
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.[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]
Nipocalimab was initially developed by Momenta Pharmaceuticals, Inc before it was acquired by Johnson & Johnson in August 2020.[1]
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 3 Vivacity-MG3 study.[7][8]
Nipocalimab is currently in clinical trials in the US
- The AZALEA pivotal Phase 3 trial focuses on pregnant individuals who are at risk of a severe HDFN pregnancy[9]
- The FREESIA pivotal Phase 3 trial focuses on patients who are at risk of an FNAIT pregnancy[10]
References
[edit]- ^ a b "J&J Snaps Up Momenta Pharmaceuticals in $6.5 Billion All-Cash Deal". BioSpace. 19 August 2020. Retrieved 30 August 2024.
- ^ "Drug trial for rare fetal blood disease shows promise for less invasive approach". ScienceDaily. Retrieved 30 August 2024.
- ^ "FDA Grants Breakthrough Therapy Designation to Nipocalimab for the Treatment of Rare Disease in Pregnancy". Pharmacy Times. 9 February 2024. Retrieved 30 August 2024.
- ^ "Search Orphan Drug Designations and Approvals". U.S. Food and Drug Administration.
- ^ "Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN". Momenta Pharmaceuticals (Press release). 28 July 2020. Retrieved 30 August 2024.
- ^ "Johnson & Johnson spotlights nipocalimab at FMF Congress 2024 – the first and only FcRn blocker to be studied in maternal fetal diseases". Janssen. Retrieved 30 August 2024.
- ^ "A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis". clinicaltrials.gov. Retrieved 30 August 2024.
- ^ MarketScreener (30 August 2024). "J&J applies to FDA for nipocalimab - MarketScreener". www.marketscreener.com. Retrieved 30 August 2024.
- ^ "A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA)". clinicaltrials.gov. Retrieved 30 August 2024.
- ^ "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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