Posted by Michael Wonder on 31 Jul 2019
Momenta Pharmaceuticals announces fast track designation for M281 (nipocalimab) in haemolytic disease of the foetus and newborn
30 July 2019 - Momenta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for M281, Momenta’s IgG1 monoclonal antibody targeting FcRn, 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 cell incompatibility exists between the blood types of a mother and baby.
Additionally, the United States Adopted Names Council, in consultation with the World Health Organisation International Nonproprietary Names Expert Committee, has adopted nipocalimab as the non-proprietary (generic) drug name for M281.
