Momenta Pharmaceuticals Announces Fast Track Designation for M281 (nipocalimab) in Hemolytic Disease of the Fetus and Newborn (HDFN)
“Obtaining Fast Track designation highlights the critical need for non-invasive, safe and effective treatment options for women at risk of HDFN. In addition, there is a broad range of rare and severe allo and autoantibody disorders in maternal fetal medicine that could benefit from the activity of nipocalimab,” said
HDFN is caused by the transfer of alloantibodies from the mother's circulatory system to the fetus during pregnancy. This transfer enables maternal antibodies to attack the red blood cells of the fetus, resulting in significant morbidity and mortality. HDFN affects an estimated 4,000 to 8,000 pregnancies each year in the U.S. with limited options available for treatment. The current standard-of-care is intrauterine blood transfusions, which are invasive and may be associated with significant complications.
Nipocalimab (M281), an investigational product, is a fully human, anti-FcRn, aglycosylated IgG1 monoclonal antibody intended to reduce the risk and severity of fetal anemia and the resulting morbidities. Nipocalimab (M281) blocks FcRn-mediated IgG recycling, thereby reducing the pathogenic alloantibodies in maternal circulation and blocks placental transfer of maternal IgG, including pathogenic alloantibodies, to the fetus.
Nipocalimab (M281) is the focus of the Unity clinical trial in HDFN led by
About the FDA’s Fast Track Program
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs. A drug granted Fast Track Designation may be eligible for several benefits, including more frequent meetings and communications with the
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Source: Momenta Pharmaceuticals, Inc.