Johnson & Johnson subsidiary Janssen (NYSE:JNJ) has revealed positive results from the proof-of-concept Phase 2 UNITY clinical trial of nipocalimab for pregnant adults with a high risk of developing severe hemolytic disease of the fetus and newborn (HDFN).
HDFN is a rare condition affecting between 3 and 80 out of 100,000 newborns or fetuses each year. The serious autoimmune disease can lead to life-threatening anemia in the fetus.
The UNITY trial met its primary endpoint with most pregnant patients who received nipocalimab giving birth to a live baby at or after 32 weeks of gestation, without the need for intrauterine transfusions.
The treatment was administered as weekly intravenous infusions to 14 participants and was well-tolerated over a 20-week period.
FDA granted nipocalimab Fast Track designation in July 2019 and orphan drug status in June 2020.
Janssen acquired nipocalimab as part of its $6.5 billion acquisition of Momenta Phar…