Janssen’s Nipocalimab Shines in HDFN Trial

Janssen reported positive topline results from a phase 2 trial of nipocalimab for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN), which occurs when blood types are incompatible. 

The trial met the primary endpoint, with the majority of pregnant patients who received nipocalimab achieving a live birth at or after 32 weeks without the need for an intrauterine transfusion throughout their entire pregnancy. 

During the treatment period of approximately 20 weeks, nipocalimab demonstrated a safety profile that supports further development of the treatment in HDFN, said Janssen.

FDA granted nipocalimab fast track designation in July 2019 and orphan drug status in June 2020. It also received orphan medicinal product designation by the European Medicines Agency in October 2019 for HDFN.

HDFN is a serious and rare condition which can cause life-threatening anemia in the fetus.