FDA批准新型口服抗血小板药物vorapaxar

美国食品药品管理局（FDA）5月8日宣布，新型抗血小板药物vorapaxar已获准用于降低有心肌梗死或外周动脉疾病史患者的心梗、卒中、心血管死亡以及需要冠脉血运重建术风险。

Vorapaxar是一种可抑制血小板凝血酶活性的蛋白酶活化受体-1（PAR-1）拮抗剂，也是这类药物中首个获批的药物。默沙东将以商品名Zontivity上市该药物，剂型为片剂。

FDA心血管和肾病药物咨询委员会在1月份召开的会议上，以10:1的投票结果推荐批准vorapaxar。

FDA药品评价与研究中心药品评价I室主任Ellis F. Unger博士在声明中指出：“对于曾有心脏病发作或患有外周动脉疾病的患者，该药物可降低心脏病发作、卒中以及心血管死亡风险。在支持该药物批准的研究中，Zontivity在3年内可使上述风险从9.5%降至7.9%，每年降低约0.5%。”

鉴于该药物增加出血风险，包括危及生命和致死性出血，因此，其处方信息中包括了一项有关这一风险的黑框警告，并随每一份处方向患者提供一份用药指南，以告知患者上述风险以及如何使用这一药物。卒中或短暂性脑缺血发作史和颅内出血史是该药物的禁忌症。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

The novel antiplatelet drug vorapaxar has been approved for reducing the risk of myocardial infarction, stroke, cardiovascular death, and need for coronary revascularization procedures in patients with a previous MI or peripheral arterial disease, the Food and Drug Administration announced on May 8.

Vorapaxar is an antagonist of protease-activated receptor-1 (PAR-1), which inhibits the action of thrombin on the platelet, and is the first drug in this class to be approved. Merck Sharp &Dohme Corp. will market the drug as Zontivity. It comes in a tablet formulation.

At a meeting in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 to recommend approval of vorapaxar.

"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," Dr. Ellis F. Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said in the FDA statement. "In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year," he noted.

Because of the increased risk of bleeding, including life-threatening and fatal bleeding, the drug’s prescribing information includes a boxed warning about this risk and a medication guide informing patients about these risks and how to use the drug will be provided with each dispensed prescription. A history of stroke, or transient ischemic attack, and a history of intracranial bleeding are contraindications.