FDA批准Johnson & Johnson的Tremfya为6岁以上患有严重皮丝虫病或关节炎的儿童使用Tremfya。 FDA approves Johnson & Johnson’s Tremfya for kids 6+ with severe psoriasis or arthritis.

美国食品和药物管理局批准了Johnson & Johnson的Tremfya (guselkumab) 治疗中度至重度斑块性牛皮或活跃牛皮性关节炎的6岁及以上儿童,体重至少40公斤. The FDA has approved Johnson & Johnson’s Tremfya (guselkumab) for children aged 6 and older with moderate to severe plaque psoriasis or active psoriatic arthritis who weigh at least 40 kg. 它是为这些儿科疾病批准的第一种IL-23抑制剂。 It is the first IL-23 inhibitor approved for these pediatric conditions. 第三阶段试验显示,56%的受治疗儿童在16周的皮肤上接近干净(IGA 0/1),而安慰剂上的比例为16%和16%,而接受治疗的儿童的血吸虫病症状改善90%(PASI 90),66%的皮肤接近干净(IGA 0/1)。 A Phase III trial showed 56% of treated children achieved a 90% improvement in psoriasis symptoms (PASI 90) and 66% reached near-clear skin (IGA 0/1) at 16 weeks, compared to 16% and 16% on placebo. 该药物在0周和4周、然后是每8周注射100毫克次皮注射。 The drug is given as a 100 mg subcutaneous injection at weeks 0 and 4, then every 8 weeks. 批准扩大了治疗方案的范围,使数千名具有这些慢性炎症的美国儿童获得治疗。 The approval expands treatment options for thousands of U.S. children with these chronic inflammatory conditions.