默沙东抗凝血剂Zontivity获FDA批准

关键词:默沙东,Zontivity,vorapaxar,抗凝血剂

2014年5月9日讯 /生物谷BIOON/ ---默沙东(Merck & Co)5月9日宣布,抗凝血剂Zontivity(vorapaxar)获FDA批准,用于遭受心脏病发作的患者或腿部动脉有堵塞的患者,以降低进一步的心脏病发作、中风、心血管死亡和需要手术的风险。

此前,FDA顾问委员会以10:1的投票结果建议批准Zontivity。

Vorapaxar是一种首创(first-in-class)的蛋白酶激活受体1(PAR-1)拮抗剂,是一种抗血小板制剂,旨在减少血小板聚集倾向,抑制血凝凝块的形成。PAR-1是一种可被凝血酶激活的受体,而凝血酶是一种有效的血小板激活剂。vorapaxar能够抑制血小板上PAR-1受体,从而抑制凝血酶诱导的血小板聚集。通过减少血液凝块的形成,Zontivity可降低心脏发作和中风的风险。

与其他抗凝血剂相似,Zontivity会增加出血风险,包括危及生命的出血和致命性出血。出血是服用Zontivity时最常报告的不良反应。该药的处方信息标签将会纳入一个黑框警告,提醒医疗专业人员了解这种风险。

Zontivity禁止用于曾发生中风、短暂性脑缺血发作(TIA)或头部出血的患者,因为这类患者头部出血风险太大。(生物谷Bioon.com)

英文原文:U.S. FDA approves Merck blood clot preventer

(Reuters) - U.S. health regulators on Thursday approved a blood clot preventer developed by Merck & Co for use by patients who have had a heart attack or who suffer from blockages in the arteries of the legs.

The drug, vorapaxar, was approved to reduce the risk of heart attacks, stroke, cardiovascular death and the need for procedures to improve blood flow to the heart, the Food and Drug Administration said.

Merck will sell the new medicine under the brand name Zontivity.

The approval follows a recommendation for its use by an FDA advisory panel that voted 10-1 in favor of the drug in January.

The approval had been delayed over safety concerns due to serious and sometimes fatal bleeding in patients who were given the drug in clinical trials.

Zontivity is not approved for use in patients who have suffered a stroke, as those patients were found to be at particularly high risk of dangerous bleeding.

"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death," Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said in a statement.

Zontivity works by preventing platelets in the blood from clumping together and forming clots in the arteries, which can lead to heart attacks and strokes.

Each year about 190,000 Americans have a second heart-related event, according to Merck. Zontivity is expected to be used in addition to standard therapy given to prevent a second heart attack - typically aspirin and the clot preventer Plavix.

 

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