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首页 » 心血病药物市场 » FDA委员会建议批准默沙东抗血小板药物vorapaxar

FDA委员会建议批准默沙东抗血小板药物vorapaxar

来源:生物谷 2014-01-16 12:02

2014年1月16日讯 /生物谷BIOON/ --默沙东(Merck & Co)1月15日宣布,FDA心血管和肾脏药物顾问委员会(CRDAC)以10比1的投票结果,建议批准该公司的抗血小板药物vorapaxar,用于近期已遭受过心脏病发作的患者群体,降低进一步心脏疾病的风险。

如果获批,vorapaxar将以商品名Zontivity上市,该药将作为一种附加药物,添加至标准疗法,用于有心脏病发作病史但无中风病史或短暂性脑缺血发作病史的患者群体,降低动脉粥样硬化事件。

FDA并不一定遵循其顾问委员会的建议,但通常都会这样做。

委员会小组成员认为,TRA 2P试验的数据强劲,可以支持vorapaxar的获批。同时该小组同意默沙东的意见,即vorapaxar不应用于有脑卒中病史的患者,因为在这一患者群体中,有升高的脑出血风险。委员会成员、斯坦福大学医学院philip Sager教授认为,vorapaxar将解决一个真正未获满足的医疗需求。

此前,FDA内部审查员已于本周一在其网站上发布了内部审查报告,同样建议批准vorapaxar,该药通过阻止血小板或血细胞紧靠一起并在动脉内形成血栓发挥作用,这些血栓会导致心脏病发作。

其他抗血小板药物,包括阿司匹林(aspirin)和百时美施贵宝(BMS)的Plavix(氯吡格雷),通过抑制名为PAR-1的受体发挥作用,这是另一种不同的作用方式。

在临床试验中,vorapaxar提高了临床试验中的整体出血风险,但在没有中风病史的患者群体中,这一出血风险没有超过该药所带来的临床益处。不过,加州大学洛杉矶分校的心脏病专家Sanjay Kaul,敦促FDA就vorapaxar的出血风险开展尽职调查。

根据默沙东,在美国,每年约有19万人会发生第二次心脏相关事件,用于预防第二事件的标准疗法,通常包括阿司匹林和Plavix。

默沙东提出,vorapaxar药物标签指示,当处方用于体重不足60公斤(132磅)的患者时,需谨慎小心,因为这一患者群体出血风险似乎比体重大于60公斤的患者群体更高。

该小组成员未能就vorapaxar应如何用于低体重患者群体的治疗达成一致的建议。FDA代表表示,在做出最终裁决之前,将继续讨论这一问题。

关于vorapaxar

Vorapaxar是一种首创(first-in-class)的蛋白酶激活受体1(PAR-1)拮抗剂,旨在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。

Vorapaxar新药申请的数据,来自一项涉及26449例患者的TRA 2P-TIMI 50试验,这是一项随机、双盲、安慰剂对照试验,将vorapaxar添加至标准疗法。纳入该研究的患者,为有心肌梗死、缺血性中风或外周动脉疾病史的患者。该项研究平均随访时间为2.5年。(生物谷Bioon.com)

英文原文:FDA advisory panel backs Merck's blood clot-preventing drug

(Reuters) - Merck & Co Inc's experimental blood clot-preventing drug vorapaxar should be approved to reduce the risk of further heart problems in people who have suffered a recent heart attack, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday.

The panel voted 10-1 in favor of the drug, which would, if approved, be sold under the brand name Zontivity. The FDA is not bound to follow the advice of its advisory panels but typically does so.

Results from a trial known as TRA 2P were "robust," panelists said, and justified approval for patients who had suffered a heart attack.

They agreed with the company that the drug should not be used in patients with a history of stroke, since there was an increased risk of bleeding in the brain in this group of patients.

"I think this drug addresses a real unmet medical need," said Dr. Philip Sager, consulting professor of medicine at Stanford University School of Medicine.

The vote followed a positive analysis by reviewers for the FDA, whose report, published on Monday, also recommended the drug be approved.

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

Other anti-platelets include aspirin and Plavix, which is made by Bristol-Myers Squibb Co. Merck's drug works in a different way, by inhibiting a receptor known as PAR-1.

The drug increased the overall risk of bleeding in clinical trials, though the risk in patients who had not had a stroke did not outweigh the drug's benefit, panelists said.

Still, Dr. Sanjay Kaul, a cardiologist and professor at UCLA School of Medicine who voted in favor of approval, urged the FDA to "do its due diligence" around the bleeding risk.

Each year about 190,000 Americans have a second heart-related event, according to Merck. Standard therapy to prevent a second episode often includes treatment with aspirin and Plavix. Vorapaxar would be given in addition to standard treatment.

"The results of today's advisory committee mark an important milestone in our effort to bring vorapaxar to appropriate patients with a history of heart attack," Dr. Daniel Bloomfield, who leads Merck's cardiovascular research, said in a statement. "We look forward to working with the FDA as it completes its review."

Merck has proposed that the drug's label urge caution when prescribing the drug for patients who weigh less than 60 kilograms (132 lbs) since the risk of bleeding in these patients appears to be higher than in heavier patients.

Panelists could not reach a consensus recommendation on how lower-weight patients should be treated. Representatives from the FDA said they will continue to discuss the matter before making their final ruling.

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