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婴幼儿血管瘤药物Hemangiol获欧盟批准

2014年5月8日讯 /生物谷BIOON/ --法国制药商皮埃尔·法布尔皮肤病学实验室(Pierre Fabre Dermatologie Laboratories)5月7日宣布,药物Hemangiol (propranolol,通用名:普萘洛尔,中文名:心得安)获欧盟委员会(EC)批准,该药是首个也是唯一一个获批用于需要全身治疗的增殖性婴幼儿血管瘤的药物。

Hemangiol是一种口服溶液,专门开发用于儿科患者。Pierre Fabre公司计划首先在法国和德国推出该药,并逐渐在其他欧洲市场推出。

此前,FDA已于2014年3月批准该药。该公司计划于今年6月将该药推向美国市场。

propranolol(普萘洛尔)对婴幼儿血管瘤的疗效,最初于2007年由波尔多大学中心医院皮肤科医生Christine Leaute-Labreze发现。随后,双方建立合作伙伴关系,开发该药用于婴幼儿血管瘤(IT)的治疗。(生物谷Bioon.com)

英文原文:Pierre Fabre gains EU approval for Hemangiol, for proliferating infantile hemangioma

French drugmaker Pierre Fabre Dermatologie Laboratories has obtained European Commission authorization to market Hemangiol (propranolol), the first and only drug to be approved for the treatment of proliferating infantile hemangioma requiring systemic treatment, the company said.

Hemangiol is an oral solution specially developed for pediatric use. It will be launched firstly in France and Germany, and gradually throughout other European markets. This European agreement follows the US Food and Drug Administration approval obtained for the same product but under the Hemangeol brand name (The Pharma Letter March 18); a launch in the USA is set for June.

This PUMA (Pediatric Use Marketing Authorization) is only the second of its type, for all pathologies, that the European Medicines Agency has issued since the system was established in 2007.

The efficacy of propranolol for the treatment of infantile hemangioma was first discovered in 2007 by Christine Leaute-Labreze, a dermatologist at Bordeaux University Hospital Center. In 2009, Pierre Fabre Dermatologie and the University of Bordeaux formed a partnership to make this discovery available to infants with infantile hemangioma (IT) under conditions specifically adapted to pediatric use. Within this framework, Pierre Fabre Dermatologie took charge of the pharmaceutical, toxicological, clinical and industrial development aspects.

关键词:血管瘤,药物

信息来源:生物谷