Posted by Michael Wonder on 28 Jul 2020
Momenta Pharmaceuticals announces FDA rare paediatric disease designation for nipocalimab in HDFN
28 July 2020 - Momenta Pharmaceuticals today announced that its novel drug candidate, nipocalimab, has received rare paediatric disease designation from the U.S. FDA for the prevention of haemolytic disease of the foetus and newborn.
Additionally, FDA granted nipocalimab orphan drug designation in haemolytic disease of the foetus and newborn
Haemolytic disease of the foetus and newborn is a serious blood disorder in a foetus or newborn that occurs when red blood cell incompatibility exists between the blood types of a mother and foetus in utero.
