SPRING HOUSE, Pa., June 26, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN).1 A statistically significant (54 percent [n=7/13]) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs)1,a compared to the historic reference point of 10 percent, which was derived from published and unpublished data.2-5,b Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.6 This study demonstrates the potential for nipocalimab to help address the underlying disease mechanism of EOS HDFN.1 If approved, nipocalimab would be the first anti-neonatal Fc receptor (FcRn) treatment and the first approved non-surgical intervention for pregnancies at high risk of HDFN in the U.S.7 These data will be presented for the first time at the Fetal Medicine Foundation World Congress in Valencia, Spain on June 26, 2023.1 Janssen is planning a pivotal Phase 3 trial for nipocalimab in pregnancies at risk for severe HDFN.