美国食品和药物管理局批准Cosentyx用于患有严重状腺炎的12岁及以上青少年,这是儿童患者这种疾病的首次向治疗.
The FDA approved Cosentyx for teens 12 and older with severe hidradenitis suppurativa, the first targeted therapy for this condition in pediatric patients.
美国食品和药物管理局批准Cosentyx (secukinumab) 适用于中度至重度上腺炎的12岁及以上的青少年,这是首次批准用于儿童患者这种疾病的向治疗.
The FDA has approved Cosentyx (secukinumab) for adolescents aged 12 and older with moderate to severe hidradenitis suppurativa, marking the first targeted therapy approved for this condition in pediatric patients.
该药物阻断了Interleukin-17A,通过下皮注射进行,在临床试验中在减少皮肤症状、疼痛和提高生活质量方面显示出成效。
The drug, which blocks interleukin-17A, is administered via subcutaneous injection and showed effectiveness in reducing skin symptoms, pain, and improving quality of life in clinical trials.
核准的依据是成人试验数据、药代动能建模和其他条件下儿科使用的安全信息。
Approval was based on data from adult trials, pharmacokinetic modeling, and safety information from pediatric use in other conditions.
治疗使用基于重量的剂量,每四个星期提供一次。
Treatment uses weight-based dosing and is given every four weeks.
该决定解决了对患有这种慢性、痛苦的皮肤病的青少年的大量未得到满足的需求,这种慢性、痛苦的皮肤疾病往往始于青春期,并可能导致长期并发症。
The decision addresses a significant unmet need for teens with this chronic, painful skin disease, which often begins in adolescence and can lead to long-term complications.