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)
SPRING HOUSE, Pa., Aug. 7, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the results from the Phase 2 open-label UNITY study of nipocalimab for the treatment of alloimmunizeda pregnant individuals at risk of early onset severe (EOS) HDFN have been published in The New England Journal of Medicine (NEJM). The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT.1 Nipocalimab is currently the only therapy reported to be in clinical development for HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the developing fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.2 These results showed that nipocalimab delayed or prevented severe fetal anemia requiring treatment prenatally and reduced the need for IUTs in pregnancies at high risk for recurrent EOS HDFN.1
Nipocalimab可以延缓或预防胎儿重度贫血,在第2期UNITY研究中,54%的研究参与者在32周或之后达到了活产且无需宫内输血(IUT)
AZALEA第3期临床研究目前正在招募患者,Nipocalimab是唯一一种用于处于严重胎儿溶血病(HDFN)风险妊娠的临床开发疗法
宾夕法尼亚州斯普林豪斯2024年8月7日电 /美通社/ -- 强生公司 (Johnson & Johnson) (NYSE:JNJ) 今天宣布,尼泊卡利单抗治疗有早发重度 (EOS) HDFN 风险的异体免疫a孕妇的 2 期开放标签 UNITY 研究结果已发表在《新英格兰医学杂志》(NEJM) 上。1 尼泊卡单抗是目前唯一一种据报道正在临床开发的治疗 HDFN 的疗法。HDFN 是一种严重而罕见的疾病,当孕妇和发育中胎儿的血型不相容时就会发生,可能导致胎儿或婴儿出现危及生命的贫血。这些结果表明,尼泊卡利单抗可延缓或预防需要产前治疗的严重胎儿贫血,并减少复发性 EOS HDFN 高风险孕妇对 IUT 的需求。