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失之东隅 收之桑榆!Medicines Company心血管药物将获得欧盟批准

来源:生物谷 2015-01-24 18:49

2015年1月24日讯 /生物谷BIOON/ --2015年刚开始,美国生物医药公司Medicines Company公司就迎来了首个利好消息。公司开发的治疗心血管疾病药物cangrelor获得欧盟医药管理部门EMA下属的人用药物委员会(Committee for Medicinal Products for Human Use, CHMP)审核通过,并建议EMA批准这一药物登陆欧洲市场。

这种药物主要是作为需要接受血管支架植入手术的患者补充治疗之用。研究显示这种药物能够防止患者的血管在接受支架植入后出现血块。不过,美中不足的是,EMA认为只有那些无法使用P2Y12基因型阻断剂药物如Plavix的患者才适用于这一药物,这一决定无疑缩小了公司原计划的适用症范围。不过无论如何,在其下属专家委员会做出这一决定后,EMA都将于未来三个月内正式批准cangrelor以Kengrexal的商品名登陆欧盟市场。

与Kengrexal同时获得通过的还有公司开发的抗生素药物oritavancin和外科用密封剂Raplixa。其中前者在经过了长达数年的波折后于去年八月份获得FDA的上市批准,而Raplixa目前仍在FDA的审核阶段之中。

Medicines Company公司CEO Clive Meanwell在声明中指出,目前在日常医疗过程中有许多亟待满足的需求,而从这一需求出发设计相应的药物则成为目前生物医药产业中一个新兴领域。CHMP能在同一天批准公司的三种产品对于公司今后的发展将起到很大作用。

不过正所谓失之东隅 收之桑榆。Medicines Company公司的好运并未能延续到在美国市场的上市审批过程中。2014年五月份Medicines Company公司向FDA提交了关于cangrelor作为血管支架术辅助疗法和心脏搭桥术辅助治疗的相关申请。FDA在审核过后要求公司重新分析其作为血管支架术辅助疗法的临床三期研究并要求其重新设计实验验证其作为心脏搭桥手术辅助治疗的有效性。这也意味着cangrelar何时能够登陆美国市场尚未可知。(生物谷Bioon.com)

详细英文报道:

European regulators are recommending approval for The Medicines Company's ($MDCO) cangrelor, setting up an overseas nod for a blood-thinning drug rejected by the FDA last year.

The drug is an intravenous therapy used to prevent blood clots in patients with coronary artery disease who need stents, designed to ward off strokes after the devices are installed. The European Medicines Agency is recommending cangrelor be used only in patients who can't take generic P2Y12 inhibitors like Plavix, a smaller indication than the company initially sought.

Such a recommendation, handed down by the EMA's Committee for Medicinal Products for Human Use (CHMP), generally results in a full European approval within about three months.

The European success for cangrelor, to be marketed as Kengrexal, is part of a big day for The Medcines Co. The CHMP also recommended the antibiotic oritavancin, approved in the U.S. last year as Orbactiv, and the surgical sealant Raplixa, whose FDA application is under review.

"At a time of increasing interest in hospital-based innovation worldwide, products designed to address significant unmet needs in acute and intensive hospital care and which offer potential efficiencies of hospital performance do not come to market too often," CEO Clive Meanwell said in a statement. "To have three positive opinions on the same day for products which have the potential to improve hospital outcomes is remarkable."

The Medicines Co. hasn't found similar luck in its home country, however, as the FDA shot down cangrelor's application in May over checkered efficacy results and missing data. The company pitched its drug for use both as an adjunct to stenting and as a bridge therapy for patients who need bypass surgery. On the former indication, the FDA instructed The Medicines Company re-analyze the data from its 11,145-patient Phase III program, and on the bridge indication, the agency requested an entirely new prospective study, putting off approval indefinitely.

 

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