The Food and Drug Administration (FDA) has granted Fast Track designation to nipocalimab (M281) for the prevention of hemolytic disease of the fetus and newborn (HDFN).
HDFN is a blood disorder that occurs during pregnancy due to red blood cell incompatibility between the mother and fetus, causing the maternal antibodies to attack the red blood cells of the fetus. Nipocalimab is a fully human, anti-FcRn, aglycosylated IgG1 monoclonal antibody that reduces pathogenic alloantibodies in maternal circulation and blocks the placental transfer of maternal IgG to the fetus.
The treatment is being evaluated in a phase 2, multicenter, open label study in pregnant women who are at high risk for early onset severe HDFN. The UNITY study is currently recruiting patients and has an estimated completion date of July 2022.
“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 Craig Wheeler, President and CEO of Momenta Pharmaceuticals. “We are pleased to receive Fast Track designation for nipocalimab in this indication and look forward to continuing our interactions with the FDA as development progresses.”
For more information visit momentapharma.com.