1月24日，欧洲药品管理局(EMA)支持批准拜耳旗下的肺动脉高压药物Adempas与葛兰素史克的糖尿病药物Eperzan。EMA也支持来自日本住友制药的精神分裂症新药Latuda及不孕症新型生物仿制药Bemfola。
但EMA决定不支持推荐梯瓦制药的新型多发性硬化症(MS)药丸Nerventra（Laquinimod），这款药物正由梯瓦制药与瑞士合作伙伴Active生物科技进行开发，另外，EMA也拒绝推荐瑞士制药商诺华心衰药物Serelaxin的上市申请。EMA人用医药产品委员会(CHMP)的上市批准推荐通常会在几个月内获得欧盟的支持。
分析师们认为Laquinimod的前景不明朗，因为这款药物在2011年的一项后期临床试验中未能达到主要终点，并且FDA声称在考虑是否批准这款药物之前要求对该药物进行另外一项3期临床研究。
伦敦杰富瑞的分析师表示，梯瓦制药多发性硬化症药物被拒绝已在预料之中，主要涉及三方面的担忧-可能与癌症风险有关、 妊娠风险及其对复发率的温和影响，这对该药物来说是一种不利的风险-效益平衡。
对于拜耳的Adempas，EMA称这款药物主要的收益是“其能够对两特殊病症，即慢性血栓栓塞肺动脉高压和肺动脉高压的运动能力和肺血液动力学提供明显的改善。”Adempas属于一类被称作可溶性鸟苷酸环化酶刺激剂的药物，它可以帮助动脉松弛，增加血流，降低血压，这款药物于去年10月份在美国及本月初在日本获得药品监管部门的支持。
EMA也对两款获得孤儿药资格的产品发布了否定意见，即法国AB Science公司用于某种类型晚期胰腺癌的Masiviera，以及PTC制药用于治疗杜氏肌营养不良的Translarna。
葛兰素史克一周注射一次的糖尿病药物阿必鲁泰（Albiglutide）赢得EMA的推荐，并将以Eperzan为商品名上市销售。这款药物与诺和诺德的利拉鲁肽，以及百时美施贵宝和阿斯利康的艾塞那肽同属GLP-1药物。去年，美国FDA曾将这款药物的批准决定推迟到今年的4月15日。
EU regulator backs Bayer, GSK drugs, knocks back Novartis, Teva
Europe's drugs regulator gave its backing on Friday for marketing approval to be granted for Bayer's pulmonary hypertension drug Adempas and for GlaxoSmithKline's diabetes medicine Eperzan.
The European Medicine Agency (EMA) also backed a new drug from Dainippon Sumitomo Pharma called Latuda, for the treatment of schizophrenia, and Bemfola, a new biosimilar medicine for the treatment of infertility.
But the regulator decided against recommending Teva's new multiple sclerosis (MS) pill Nerventra, or laquinimod, which the Israeli firm is developing with Swedish partner Active Biotech, and recommended rejecting an application from Swiss drugmaker Novartis to market its heart failure drug serelaxin.
Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
The prospects for laquinimod were already viewed by analysts as uncertain, since the drug missed its main goal in a late-stage trial in 2011 and U.S. regulators have asked for another Phase III study before considering it.
Analysts at Jefferies in London said the rejection of Teva's MS drug was as they had expected and was driven by three major concerns - about the possible link to risk of cancers and pregnancy dangers, and its modest effect on relapse rates which suggested an unfavorable risk-benefit balance for the drug.
On Bayer's Adempas, the EMA said the key benefits of the drug were "its ability to provide significant improvement in exercise capacity and pulmonary haemodynamics in two specific conditions known as chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension."
Adempas, which belongs to a class of drugs known as soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure, got backing from drugs regulators in United States in October last year, and in Japan earlier this month.
The EMA also issued negative opinions for two so-called orphan medicines - Masiviera from France's AB Science, intended for certain types of advanced pancreatic cancer, and Translarna, from PTC Therapeutics, designed to treat Duchenne muscular dystrophy.
GSK's once-weekly diabetes drug albiglutide won the EMA's recommendation and will be sold under the brand name Eperzan. It belongs to the same class of injectable GLP-1 drugs as Victoza, from Novo Nordisk, as well as Byetta and Bydureon, from Bristol-Myers Squibb and AstraZeneca.
Last year regulators in the United States pushed back an approval decision on the drug until April 15.
关键词： 住友制药 精神分裂症 新药 Latuda EMA 支持
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