Press releases

Nipocalimab delayed or prevented severe fetal anemia and 54 percent of study participants in the Phase 2 UNITY study achieved a live birth at or after 32 weeks without the need for intrauterine transfusion (IUT) The AZALEA Phase 3 clinical study is currently enrolling patients: Nipocalimab is the only therapy in clinical development for use in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN)

FNAIT is a rare disease that occurs when a pregnant person’s immune system attacks fetal platelets, resulting in the risk of internal bleeding, which can be life threatening to the fetus or newborn The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported to be in clinical development for the treatment of FNAIT

Presentations include additional analyses of nipocalimab data from pregnancies at risk for early-onset severe HDFN; Nipocalimab is the only anti-FcRn being studied in this rare and potentially life-threatening two-person disease for which there are no approved non-surgical therapies

Breakthrough Therapy Designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for HDFN Phase 3 clinical trial enrollment underway, representing the only therapy reported to be under clinical development for this serious, life-threatening and rare condition

92 percent of pregnancies treated with nipocalimab resulted in a live birth, with 54 percent delivering at or after 32 weeks without intrauterine transfusions1

There are currently no approved therapeutics for the treatment of HDFN which, in severe cases, can cause life-threatening anemia in the fetus