Momenta Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for M281, Momenta’s IgG1 monoclonal antibody targeting FcRn, in Hemolytic Disease of the Fetus and Newborn (HDFN). HDFN is a serious blood disorder in a fetus or newborn that occurs when red cell incompatibility exists between the blood types of a mother and baby. Additionally, the United States Adopted Names Council (USAN), in consultation with the World Health Organization (WHO) International Nonproprietary Names Expert Committee, has adopted nipocalimab as the nonproprietary (generic) drug name for M281. 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 Kenneth Moise, MD, a maternal-fetal medicine specialist at The University of Texas Health Science Center at Houston (UTHealth). Moise is the principal investigator for the global study. He is also a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences and Department of Pediatric Surgery with McGovern Medical School at UTHealth and co-director of The Fetal Center at Children’s Memorial Hermann Hospital in collaboration with UT Physicians. McGovern Medical School at UTHealth is the first site in the U.S. to be open for enrollment in this global clinical trial. Additional clinical trial information can be found here.