2013年7月25日訊 /生物谷BIOON/ --默沙東（Merck & Co）7月24日宣布，F(xiàn)DA已接受審查其抗凝血?jiǎng)﹙orapaxar的上市申請(qǐng)（MA)，該藥旨在用于既往有心臟病發(fā)作病史但無(wú)中風(fēng)病史的患者，預(yù)防心臟病發(fā)作和中風(fēng)。
默沙東于2009年通過(guò)收購(gòu)競(jìng)爭(zhēng)對(duì)手先靈葆雅（Schering-Plough）獲得vorapaxar，該藥一度被認(rèn)為是一個(gè)潛在的重磅產(chǎn)品，有望成為華法林（warfarin）有前途的接班人。
但vorapaxar的前景在2011年枯萎，一個(gè)安全委員會(huì)監(jiān)督一項(xiàng)涉及26000例患者的研究TRA-2P時(shí)稱，該藥不適合那些已遭受過(guò)一次中風(fēng)的患者，因?yàn)樵撍幨钩鲅L(fēng)險(xiǎn)升高。一些分析師稱，該藥物估計(jì)永遠(yuǎn)不會(huì)出現(xiàn)在銷售代表手中。
默沙東之后被允許在心臟病發(fā)作或被診斷為腿部動(dòng)脈堵塞但病情穩(wěn)定的患者中繼續(xù)推進(jìn)該項(xiàng)研究。有中風(fēng)病史的患者從該試驗(yàn)中被排除。
該項(xiàng)研究的目的是觀察，vorapaxar是否能在更有限的患者群體中安全地用于預(yù)防心臟病發(fā)作和中風(fēng)。
盡管現(xiàn)已完成的試驗(yàn)和一個(gè)單獨(dú)的早期研究TRACER試驗(yàn)的數(shù)據(jù)均好壞參半，但默沙東去年夏天稱，將繼續(xù)尋求vorapaxar的獲批。
但一些分析師警告稱，即便vorapaxar獲批，由于出血風(fēng)險(xiǎn)，該藥應(yīng)用的患者數(shù)量可能十分有限。（生物谷Bioon.com）
英文原文：FDA accepts review of long-delayed Merck blood clot drug
July 24 - Merck & Co. on Wednesday said U.S. regulators had accepted its marketing application for the blood clot drug vorapaxar, aimed at preventing heart attacks and strokes in patients who have already had a heart attack but who have no history of stroke.
The experimental drug, acquired by Merck through its 2009 acquisition of rival U.S. drugmaker Schering-Plough Corp., was once considered a potential blockbuster product.
But its prospects wilted in 2011 when a safety committee overseeing a 26,000-patient study, called TRA-2P, said the new type of anti-platelet drug was not appropriate for patients who had already suffered a stroke because the drug raised bleeding risk.
Merck was allowed to press ahead with the trial, one of the largest heart-drug studies ever conducted, among patients who were in stable condition after having heart attacks or being diagnosed with clogged leg arteries. Patients who had suffered strokes were excluded from the trial.
The study's aim was to see if vorapaxar could prevent heart attack and stroke in that more-limited patient population and whether it could do so safely, given the drug's established bleeding risk.
Despite mixed results of the now-completed trial and the drug's failure in a separate earlier study called TRACER, Merck last summer said it would seek approval of vorapaxar.
"Despite the use of standard therapy, there continues to be residual risk of additional heart attacks in these patients," Merck spokeswoman Pam Eisele said on Wednesday, citing the need for new drugs like vorapaxar, which works through a different mechanism than existing medicines.
But some analysts have cautioned that even if approved, it would likely be used by a limited number of patients because of the bleeding risk.
Merck shares slipped 0.6 percent to $47.63 in morning trading on the New York Stock Exchange.
