根据有力的试验结果,FDA批准Tremfya为患有严重皮丝虫病或关节炎的6岁以上6岁以上儿童提供Tremfya。 FDA approves Tremfya for kids 6+ with severe psoriasis or arthritis, based on strong trial results.

美国食品和药物管理局批准Tremfya (guselkumab) 适用于6岁及以上的儿童,患有中度至重度斑块性牛皮或活跃牛皮性关节炎,需要全身治疗或光疗. The FDA has approved Tremfya (guselkumab) for children aged 6 and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis who need systemic therapy or phototherapy. 这是第一种经批准用于儿科用途的中叶基-23抑制剂。 It is the first interleukin-23 inhibitor approved for pediatric use. 根据PROTOSTAR试验结果,56%的接受治疗的儿童在16周前皮肤症状至少改善了90%,而安慰剂的发病率为16%,66%的儿童接近完全或完全通过检查。 Based on the PROTOSTAR trial, 56% of treated children achieved at least 90% improvement in skin symptoms by week 16, compared to 16% on placebo, with 66% reaching near-complete or complete clearance. 该药物显示了一种有利的安全特征,并解决了在治疗儿童这些慢性免疫媒介疾病方面未得到满足的巨大需求。 The drug showed a favorable safety profile and addresses a significant unmet need in treating these chronic immune-mediated conditions in children.