European Medicines Agency, 7 Westferry Circus, London, E14 4HB, UK.
Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
Eur J Dermatol. 2014 Jul-Aug;24(4):457-63. doi: 10.1684/ejd.2014.2368.
The European Commission has recently issued a marketing authorisation valid throughout the European Union for ingenol mebutate (Picato) in the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
The objective of this paper is to summarise the scientific review of the application leading to regulatory approval in the EU. The full scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (www.ema.europa.eu).
MATERIAL & METHODS: The application was supported by 25 clinical studies, of which 18 were performed in patients with actinic keratosis.
The active substance is a pure ingenol angelate obtained from the aerial parts of the plant species Euphorbia peplus by extraction and purification. One tube of ingenol mebutate 150 mcg/g gel or 500 mcg/g gel should be applied once daily to the affected area for 3 or 2 consecutive days on the 'face and scalp' or 'trunk and extremities', respectively. Complete response rate is 42.2% on the 'face and scalp' and 34.1% on the 'trunk and extremities'. The most common side effects are local skin responses including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration at the application site.
The benefits of ingenol mebutate are its ability to improve the complete response rate of actinic keratosis, the short duration of treatment and the ease of self-application.
欧盟委员会最近发布了一项在欧盟范围内有效的上市许可，用于治疗成人非角化性、非肥厚性光化性角化病的皮内制剂 ingenol mebutate（Picato）。
本文旨在总结导致欧盟监管批准的申请的科学审查。完整的科学评估报告和产品信息，包括产品特性摘要，可在 EMA 网站（www.ema.europa.eu）上查阅。
该申请得到了 25 项临床研究的支持，其中 18 项是在光化性角化病患者中进行的。
活性物质是一种从植物 Euphorbia peplus 的地上部分提取和纯化得到的纯 ingenol angelate。每天在“面部和头皮”或“躯干和四肢”上使用 1 管 ingenol mebutate 150 mcg/g 凝胶或 500 mcg/g 凝胶，连续使用 3 天或 2 天。“面部和头皮”上的完全缓解率为 42.2%，“躯干和四肢”上的完全缓解率为 34.1%。最常见的副作用是局部皮肤反应，包括应用部位的红斑、脱屑/结痂、结痂、肿胀、水疱/脓疱和糜烂/溃疡。
ingenol mebutate 的益处在于它能够提高光化性角化病的完全缓解率、治疗持续时间短以及易于自我应用。
