智通财经APP获悉，强生(JNJ.US)宣布已向美国FDA提交补充生物制品许可申请(sBLA)，寻求批准其抗IL-23抗体Tremfya(guselkumab)作为皮下注射(SC)诱导方案，用于治疗中度至重度活动性溃疡性结肠炎(UC)的成人患者。
据悉，Tremfya是一款全人源单克隆抗体。除了靶向IL-23，该抗体也可同时与生产IL-23细胞上的受体CD64相结合。IL-23是由活化的单核细胞/巨噬细胞和树突状细胞分泌的细胞因子，是UC等免疫介导疾病的驱动因素。
公开资料显示，Tremfya于2024年9月获得FDA批准，作为静脉注射(IV)诱导方案用于治疗中度至重度活动性UC的成人患者，患者并在随后进行皮下注射维持治疗。这一批准基于3期QUASAR研究的数据，该研究验证了Tremfya在UC患者中的疗效和安全性。此外，Tremfya用于治疗中度至重度活动性克罗恩病(CD)的申请已提交至美国FDA，而针对UC和CD的申请也已提交至欧洲监管机构。
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