国家药监局批准非激素外用PDE4抑制剂舒坦明(克立硼罗)用于特应性皮炎治疗

2020-08-04 生物谷 生物谷

辉瑞(Pfizer)近日宣布,中国国家药品监督管理局(NMPA)已正式批准舒坦明(克立硼罗)2%软膏剂的进口药品注册证。舒坦明在中国被批准用于2岁及以上轻度至中度特应性皮炎(AD)患者的局部外用治疗。

辉瑞(Pfizer)近日宣布,中国国家药品监督管理局(NMPA)已正式批准舒坦明(克立硼罗)2%软膏剂的进口药品注册证。舒坦明在中国被批准用于2岁及以上轻度至中度特应性皮炎(AD)患者的局部外用治疗。
 
特应性皮炎(AD,也称为特应性湿疹)是最常见的慢性炎症性皮肤病,以反复发作的慢性湿疹样皮疹为主要表现,伴有显著的皮肤干燥和瘙痒。在世界范围内,高达10%的成人和20%的儿童患有特应性皮炎。随着生活方式和环境的改变,近10余年间中国特应性皮炎的患病率不断升高,受累及的人群涉及各年龄段。中国特应性皮炎诊疗指南(2020版)指出,我国12个城市1-7岁儿童特应性皮炎患病率达到12.94%,1-12月婴儿特应性皮炎患病率达30.48%。
特应性皮炎(图片来源:diseaseslab.com)
 
特应性皮炎的皮肤表现可从儿童期持续到成年。婴儿期皮损大多在2岁以内起病,患儿将出现皮损和剧烈的瘙痒,严重影响其睡眠和生长发育;随着病情进展,还容易伴发哮喘、过敏性鼻炎和过敏性结膜炎,给患者和其家庭带来持续不断的困扰。成人特应性皮炎通常伴随明显的瘙痒症状,表皮剥脱、水疱、渗出和浆液性结痂,可引发患者情绪负担、失眠、抑郁和焦虑等精神疾病,导致生产力和社会功能的下降甚至丧失,严重影响患者的生活质量。
 
舒坦明(克立硼罗)2%软膏剂是一个新型的小分子、非激素、非甾体类抗炎的磷酸二酯酶4 (PDE-4)抑制剂,过度活化的PDE-4已被证明与特应性皮炎的症状和体征有关。
舒坦明(克立硼罗)2%软膏剂
 
2016年,舒坦明获得美国食品药品管理局(FDA)批准,适用于治疗2岁及以上患者的轻中度特应性皮炎,该产品在美国的商品名为EUCRISA,北美以外地区商品名为STAQUIS。2020年,美国FDA批准将其适应症扩展为3月龄及以上的儿童和成人轻度至中度特应性皮炎的局部治疗。目前,舒坦明已在美国、加拿大、澳大利亚、以色列和欧盟地区获批用于治疗特应性皮炎。
 
得益于NMPA相关政策的推动,舒坦明通过快速审批通道进入中国,该药的批准标志着一个重要的里程碑,将填补中国儿童特应性皮炎未被满足的治疗需求,为广大的中国特应性皮炎患者尤其是2岁及以上的儿童患者提供了缓解症状的机会。
值得一提的是,今年6月,赛诺菲公司达必妥®(英文名:Dupixent®,通用名:度普利尤单抗,dupilumab)在中国获得批准,用于治疗成人中重度特应性皮炎(AD)。今年2月,《中国特应性皮炎治疗指南(2020)》发布,将尚未上市的达必妥®列入推荐,以期待这一新药能够填补目前药物无法满足的需求。
 
达必妥®是全球首个也是唯一获批治疗成人中重度特应性皮炎的靶向生物制剂,填补了国内临床未被满足的需求,能快速、显著、持续地改善特应性皮炎患者的皮损程度和瘙痒症状。得益于药监改革的推动,达必妥®提前2年在中国获批,为中国患者提供了全新的治疗选择。
 
达必妥®是一款全人单克隆抗体,能够通过“双靶点”的创新作用机制,选择性地抑制关键信号通路白介素4(IL-4)和白介素13(IL-13),阻断2型炎症通路,降低2型炎症的病理性反应,从机制上治疗2型炎症相关疾病。
 
达必妥®由赛诺菲和再生元联合开发,截至目前,该药已被批准治疗3种由2型炎症导致的疾病:中度至重度特应性皮炎(≥6岁患者)、中度至重度哮喘(≥12岁患者)、伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP,成人患者)

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    2020-10-24 jklm09
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    2020-08-06 xuyu
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    2020-08-04 ms5000002013538670

    感谢分享!

    0

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    2020-08-04 zhaojing6889

    👍👍👍

    0

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