Johnson & Johnson's Nipocalimab Granted Breakthrough Designation for Hemolytic Disease Treatment

Johnson & Johnson announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab, marking a significant milestone in its development as a potential treatment for alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN), a condition that poses life-threatening risks due to incompatible blood types between the pregnant individual and the fetus, with nipocalimab being the only therapy reported to be in clinical development for this rare and serious condition, emphasizing Johnson & Johnson's commitment to addressing the substantial unmet needs in this devastating disease.