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可以延緩或預防胎兒重度貧血,在第2期UNITY研究中,54%的研究參與者在32周或之後達到了活產且無需宮內輸血(IUT)
AZALEA第3期臨床研究目前正在招募患者,Nipocalimab是唯一一種用於處於嚴重胎兒溶血病(HDFN)風險妊娠的臨床開發療法
賓夕法尼亞州斯普林豪斯2024年8月7日電 /美通社/ -- 強生公司 (Johnson & Johnson) (NYSE:JNJ) 今天宣佈,尼泊卡利單抗治療有早發重度 (EOS) HDFN 風險的異體免疫a孕婦的 2 期開放標籤 UNITY 研究結果已發表在《新英格蘭醫學雜誌》(NEJM) 上。1 尼泊卡單抗是目前唯一一種據報道正在臨床開發的治療 HDFN 的療法。HDFN 是一種嚴重而罕見的疾病,當孕婦和發育中胎兒的血型不相容時就會發生,可能導致胎兒或嬰兒出現危及生命的貧血。這些結果表明,尼泊卡利單抗可延緩或預防需要產前治療的嚴重胎兒貧血,並減少複發性 EOS HDFN 高風險孕婦對 IUT 的需求。