The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ) FcRn blocker nipocalimab into its fast-track program for development as a therapy to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults. This move comes after the drug was classified as an orphan drug last year, highlighting the lack of treatments in development for FNAIT, a rare condition where a mother’s immune system targets the fetus’s platelets.
Nipocalimab is in the late stages of development for FNAIT and is also currently undergoing a Phase II trial for hemolytic disease of the fetus and newborn (HDFN), a related condition impacting fetal red blood cells. Although the exact mechanism of action is yet to be confirmed, nipocalimab is hypothesized to prevent the transference of alloantibodies from an alloimmunized mother to the fetus via the placenta, thereby protecting the infant’s broader immune system.- Flcube.com
