上一篇:第一个儿科批准
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Paediatric drugs
|November 22, 2024
概括
阿普雷米拉斯特 (Otezla®) 是一种PDE-4抑制剂,现在已在美国和欧盟批准用于小儿斑块牛皮. 这标志着在6岁及以上儿童中治疗中度至重度病例的重要里程碑.
科学领域:
- 皮肤病学 皮肤病学
- 药理学 药理学是指药理学的学科.
- 儿科 儿科 儿科
背景情况:
- 阿普雷米拉斯特 (Otezla®) 是一种基化酶-4 (PDE-4) 抑制剂.
- 目前已批准用于患有牛皮关节炎,斑块牛皮和贝塞特病口腔的成年人.
- 儿童使用斑块牛皮以前没有解决.
研究的目的:
- 总结一下前期发展的关键里程碑.
- 突出监管途径导致其首次获得小儿病治疗斑块牛皮的批准.
主要方法:
- 对6至17岁的儿科患者的临床数据的审查.
- 分析美国和欧盟的监管提交和批准.
主要成果:
- 阿普雷米拉斯特于2024年4月在美国首次获得儿科批准,用于在6岁以上的患者中适度至严重的斑块性牛皮.
- 欧盟在2024年10月批准了apremilast用于相同的适应症,用于6岁以上的儿童和青少年.
- 这两项批准都基于符合特定体重和疾病严重程度标准的儿科患者的临床数据.
结论:
- 现在,阿普雷米拉斯特是美国和欧盟的儿科患者中度至重度斑块性牛皮的批准治疗选择.
- 这种扩大适应症解决了年轻患者需要全身疗法或光疗的关键未满足需求.
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