Momenta med nabs Rare Pediatric Disease tag for anemia in newborns

The FDA has signed off on Rare Pediatric Disease designation for Momenta Pharmaceuticals’ (NASDAQ:MNTA) nipocalimab for the prevention of hemolytic disease of the fetus and newborn, a rare disorder in babies in which red blood cells break down at a fast rate, a condition called erythroblastosis fetalis, caused by incompatibility between maternal and fetal blood groups. It occurs in 3K – 8K U.S. pregnancies each year.

Rare Pediatric Disease Designation provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.

Nipocalimab is a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody engineered to reduce circulating IgG antibodies by blocking IgG recycling.

https://seekingalpha.com/news/3595823-momentas-nipocalimab-nabs-rare-pediatric-disease-tag-for-anemia-in-newborns