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沙雷霉素:首次全球批准。

Sarecycline: First Global Approval.

机构信息

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2019 Feb;79(3):325-329. doi: 10.1007/s40265-019-1053-4.

DOI:10.1007/s40265-019-1053-4
PMID:30659422
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6505496/
Abstract

Sarecycline (Seysara™) is an oral, once-daily, tetracycline-class drug for which a tablet formulation is approved in the USA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged ≥ 9 years. The drug was developed by Paratek and Allergen and later acquired by Almirall S.A. (a Barcelona-based pharmaceutical company focused on medical dermatology). Sarceycline tablets were approved in early October 2018 and are planned to be available for patients in January 2019. Sarecycline capsules have also been studied in the USA, but no recent reports of development have been identified for this formulation. There are currently no clinical trials underway assessing sarecycline in rosacea. This article summarizes the milestones in the development of sarecycline leading to this first approval for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

摘要

沙瑞环素(Seysara™)是一种口服、每日一次的四环素类药物,其片剂剂型已获美国批准用于治疗 9 岁及以上患者的非结节性中重度寻常痤疮的炎性皮损。该药物由 Paratek 和 Allergen 开发,后由 Almirall S.A.(一家专注于医学皮肤病学的巴塞罗那制药公司)收购。沙瑞环素片剂于 2018 年 10 月初获得批准,计划于 2019 年 1 月为患者提供。沙瑞环素胶囊也已在美国进行研究,但最近未发现该剂型的开发报告。目前尚无正在进行的评估沙瑞环素治疗酒渣鼻的临床试验。本文总结了沙瑞环素研发过程中的重要里程碑,最终该药获得批准用于治疗非结节性中重度寻常痤疮的炎性皮损。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0445/6505496/759aa4caa396/40265_2019_1053_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0445/6505496/f9dc072d8183/40265_2019_1053_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0445/6505496/759aa4caa396/40265_2019_1053_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0445/6505496/f9dc072d8183/40265_2019_1053_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0445/6505496/759aa4caa396/40265_2019_1053_Figb_HTML.jpg

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2
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