新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 冠心病 » Medicines抗血小板药物cangrelor终于迎来获批的曙光

Medicines抗血小板药物cangrelor终于迎来获批的曙光

来源:生物谷 2015-04-17 11:48

2015年4月17日讯 /生物谷BIOON/ --Medicines公司注射用抗血小板药物cangrelor(坎格雷洛)终于迎来了曙光。去年2月,FDA专家委员会认为cangrelor临床试验项目存在太多问题,一致投票反对批准该药。之后Medicines公司对III期项目数据进行了重新分析并缩小适应症,这一次终于赢得了FDA专家委员会的祝福,该委员会以9:2的投票结果支持批准cangrelor,认为该公司已解决了大型III期项目中存在的问题。FDA会参考该委员会的建议,将于6月23日做出最终审查决定。

cangrelor是一种短效静脉注射用抗血小板药物,用于需要接受血管支架植入手术的冠状动脉疾病患者预防血液凝块,该药旨在防止支架植入后患者出现中风。cangrelor是一种短效血小板P2Y12抑制剂,半衰期仅3-5分钟,在停止输注后1小时内血小板功能可恢复正常。而口服P2Y12抑制剂氯吡格雷(clopedogrel)具有较长的延迟作用,其作用在停药后仍可持续数天。

cangrelor的大型III期项目涉及近1.2万例患者,持续开展时间长达9年。业界曾预计cangrelor在巅峰时的年销售额将达到4亿美元。然而,市场在近几年已发生了变化,加之cangrelor被缩小的适应症,ISI集团分析师认为该药的年销售峰值仅为1亿美元。

在欧盟,cangrelor已于2015年3月底获得批准,商品名为Kengrexal,该药是欧盟批准的首个也是唯一一个静脉抗血小板药物,可提供即时、一致、迅速可逆的P2Y12抑制作用。Medicines公司在同一时间获欧盟批准的还有抗生素Orbactiv(oritavancin,奥利万星,静脉注射液)和止血剂Raplixa(纤维蛋白原/凝血酶,粉末)。此前,Orbactiv已于2014年8月获得FDA批准,用于敏感革兰氏阳性菌(包括耐甲氧西林金黄色葡萄球菌,MRSA)导致的急性细菌性皮肤和皮肤结构感染(ABSSSIs)成人患者的治疗;在美欧2大市场,Orbactiv是获批治疗ABSSSIs的唯一一种单剂量治疗方案的抗生素。Raplixa则是首个即用型、具有生物活性的、粉末状纤维蛋白封闭剂,可为广泛的出血状况提供止血作用。(生物谷Bioon.com)

英文原文:Medicines Co.'s cangrelor finally lines up for FDA approval

A panel of FDA advisers reversed its earlier derision and voted in favor of The Medicines Company's ($MDCO) long-delayed blood thinner, spelling a likely approval for the drug after years of setbacks.

The treatment, cangrelor, 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 agency's independent cardio committee voted 9-2 with one abstention in favor of recommending the drug for approval, satisfied the company addressed some lingering concerns tied to its 11,145-patient Phase III program.

The FDA is not required to follow the votes of its advisers, though it commonly does, and the agency is slated to hand down a final decision on cangrelor by June 23.

The panel's change of heart follows a stinging 2014 rejection in which the committee pilloried The Medicines Company's pivotal program, taking issue with how the company analyzed its Phase III data and threw out cangrelor's case for use as a bridge therapy for those undergoing surgery. To sway regulators, the company reanalyzed the data in question and narrowed its ambitions, curtailing its intended indication to patients who can't handle standard platelet inhibitors.

An approval would bring to a close 9 plodding years of Phase III development for cangrelor, a drug once expected to bring in about $400 million a year at its peak. The market has changed in the ensuing years, however, and evolving standards of care coupled with cangrelor's likely narrow indication put it in line for just $100 million in peak annual sales, according to Evercore ISI's Umer Raffat.

The company convinced European regulators to approve cangrelor last month, marketing the drug Kengrexal.

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库