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【原创】左西替利嗪在欧洲获准用于顽固性变应
比利时联合化学公司(UC受让自美国塞普拉柯(Sepracor)公司的抗组安剂Xyzal（levocetirizine，左西替利嗪），最近在欧盟15国（14个老欧盟成员国加上挪威）通过相互承认程序获准用于顽固性变应性鼻炎新适应症。此前，该品已在欧洲获准用于变应性鼻炎和成人及六岁以上儿童的慢性特发性荨麻疹。
Xyzal适应症的扩展是基于一项XPERT研究(治疗顽固性鼻炎的安慰剂对照试验)的结果：在一项有551个患有顽固性变应性鼻炎病人参加的为期6个月的研究中，发现左西替利嗪对顽固性变应性鼻炎症状的缓解自始至终比安慰剂更有效。显然，该新适应症的获准不但有助于Xyzal销售额的提高，还将成为UCB公司利润增长的一个关键驱动力。
UCB强调，Xyzal是获准6个月持续治疗的第一个抗组织胺药，不但可减少相关疾病的治疗费用，并且还将改善患者的生存质量。
S00868254 - Scrip Top
Date published: 30 December 2004
Xyzal approved in EU for persistent allergic rhinitis:
UCB's antihistamine, Xyzal (levocetirizine, licensed from Sepracor), has been approved in the 15 member states that made up the old EU plus Norway for use in patients with persistent allergic rhinitis via the mutual recognition procedure. The expanded indication is based on the results of the XPERT trial - a six-month study in 551 patients with persistent allergic rhinitis which found that levocetirizine was more effective than placebo in relieving symptoms throughout the duration of the study. The product also improved quality of life and decreased the costs of the disease on society, UCB says. Xyzal is the first antihistamine to receive approval for six months' continuous treatment, it adds. The new indication should help boost sales of the product, which is one of the key growth drivers for the firm. Xyzal is already approved in Europe for allergic rhinitis, and for chronic idiopathic urticaria in adults and children over six years old.
Full title: SCRIP - World Pharmaceutical News - www.scrippharma.com
FILED 30 December 2004 COPYRIGHT Informa UK Ltd 2004 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-03-24 14:07
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