FDA扩大EUCRISA(Crisaborole)软膏适应症:至3个月大的轻中度特应性皮炎患儿

2020-03-25 Allan MedSci原创

AD是一种慢性皮肤病,其特征在于皮肤发炎和皮肤屏障缺陷,在美国约有1800万人和约11%的儿童受到影响。

辉瑞公司今天宣布,美国FDA已批准其EUCRISA®(crisaborole)软膏的补充新药申请(sNDA),将EUCRISA(Crisaborole)软膏适应症扩展至3个月大的轻中度特应性皮炎患儿。EUCRISA先前已获批准用于成人和2岁及以上的儿童。该补充批准使EUCRISA成为第一个也是唯一适用于3个月大的轻中度AD患儿的局部处方药。

加州大学圣地亚哥分校皮肤科和儿科教授Lawrence Eichenfield博士说:“患者家庭每天需要花费数小时缓解孩子的湿疹症状,这是艰辛的,并且会给整个家庭造成伤害。EUCRISA的批准为这些非常年幼的患者提供了潜在的缓解方法”。

AD是一种慢性皮肤病,其特征在于皮肤发炎和皮肤屏障缺陷,在美国约有1800万人和约11%的儿童受到影响。

 

原始出处:

https://www.firstwordpharma.com/node/1710324

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    2020-03-27 闆锋旦
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特应性皮炎(AD)是最常见的儿科皮肤病,该研究表明童年AD对家庭的全面影响遍及整个生命过程。这些发现突显了对AD儿童进行更好治疗的必要性,以减轻儿科患者及其家人的巨大负担。