智通财经APP获悉，强生(JNJ.US)日前宣布，美国FDA已授予其靶向新生儿Fc受体(FcRn)的在研抗体疗法nipocalimab突破性疗法认定(BTD)，用于治疗中度至重度干燥综合征(Sjögren’s disease，SjD)成人患者。根据新闻稿，nipocalimab是在SjD领域获得BTD的首个疗法。值得一提的是，这款疗法今年年初被行业媒体Evaluate列为10大潜在重磅在研疗法之一。
Nipocalimab是一款潜在“best-in-class”，靶向FcRn的抗体疗法。它通过与FcRn结合，让被单核细胞和内皮细胞摄入的自身抗体不会重新释放到血液中，而是在细胞内被降解。已有研究显示，它可以将血液循环中包括致病自身抗体在内的IgG水平降低超过75%。这款抗体疗法有望治疗多种自身抗体介导的免疫疾病。
此前，它已经获得FDA授予的突破性疗法认定，用于治疗有高风险出现严重新生儿溶血病(HDFN)的孕妇。Nipocalimab在治疗成人全身性重症肌无力(gMG)成人患者的关键性3期临床试验VIVACITY中也已获得积极顶线结果。
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