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强生拜瑞妥(Xarelto)ACS适应症遭FDA委员会否决

来源:生物谷 2014-01-17 08:13

2014年1月17日讯 /生物谷BIOON/ --1月16日,FDA心血管和肾脏药物顾问委员会(CRDAC)以10:0,1票弃权的投票结果,建议不批准强生(JNJ)拜瑞妥(Xarelto)急性冠脉综合征(ACS)新适应症申请。该委员会认为,强生所提交的来自单个临床试验的数据,并没有强大到支持Xarelto用于该适应症,尤其是一些数据的缺失。强生所提交的这些数据,旨在证明,对于那些在近期已遭受了一次心脏病发作的患者群体,Xarelto能够有效地降低进一步的心脏问题的风险。

FDA并不一定遵循其顾问委员会的建议,但通常都会这样做。

该委员会的投票结果与FDA内部审查员的审查结果一致。此前,FDA在其网站发布了内部审查意见,同样指出,没有证据表明强生Xarelto能够提供更显著的临床利益。

委员会小组成员表示,强生所提交的额外数据,并没有改变他们的看法,Xarelto所显示出的临床利益,并没有超过其升高的出血风险。该委员会成员还表示,从整体临床数据中摘取出一段为期90天的时间框架,并对药物的安全性或疗效下确定性的结论,这是不可取的。

FDA心血管和肾脏药物部门副主任Stephen Grant博士表示,一种药物,基于单个临床试验达到获批的标准是,需要证明它在某些方面优于现有产品。

强生旗下杨森临床开发部副总裁Paul Burton博士称,将与FDA合作,解决CRDAC委员会所提出的问题。

目前,Xarelto已获批用于治疗和预防深静脉血栓和肺动脉栓塞,同时获批用于并非由心脏问题引发的不规则心脏跳动患者,以降低中风风险和减少血液凝块。现在,强生希望FDA批准Xarelto用于急性冠脉综合征(ACS)。(生物谷Bioon.com)

英文原文:FDA advisory panel rejects J&J drug for acute coronary syndrome

Jan 16 (Reuters) - Johnson & Johnson's anticoagulant Xarelto should not be approved to prevent further heart problems in patients who have recently suffered a heart attack, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

The panel voted 10 to 0, with one abstention, that data presented by the company from a single clinical trial was not strong enough to justify approval, especially since some data from was missing.

The FDA is not bound to follow the advice of its advisory panels but typically does so.

Xarelto is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems.

The company had hoped to also win approved for its use in patients with acute coronary syndrome (ACS), an umbrella term covering any condition brought on by a sudden, reduced blood flow to the heart, including heart attack and chest pain.

The vote follows a negative review from staff at the FDA whose report, published on Tuesday, noted that there was no proof the drug confers significant benefit.

Dr. Paul Burton, vice president of clinical development at Janssen Research and Development, a J&J unit, said in a statement that the company will "work with the FDA to address questions raised today."

J&J originally filed for approval of Xarelto in ACS at the end of 2011. The FDA rejected the application, citing missing data, and said the trial results were not strong enough to support approval. The company retrieved some missing data but the FDA once again declined to approve the drug, prompting J&J to appeal the decision.

The FDA denied the appeal but said limiting the duration of use to one month might be a pathway forward because efficacy was more evident and the risk of bleeding, a side effect of the drug, was lower during this period. J&J filed a new application seeking a treatment duration of 90 days.

Panelists said the inclusion of J&J's additional data did not alter their view that the benefit of the drug was not shown to outweigh an increased risk of bleeding.

Neither did they think it was possible to carve out a 90-day time frame from the overall clinical data and make definitive conclusions about the drug's safety or efficacy.

"Looking at the overall study it wasn't robust enough in terms of statistical significance to be considered a positive study, and with that it was not possible to look at subgroups," said Dr. Philip Sager, consulting professor of medicine at Stanford University School of Medicine.

Dr. Stephen Grant, deputy director of the FDA's division of cardiovascular and renal drugs, said the benefit of the drug met the criteria required to approve a drug based on a single trial - namely, proof it was superior in some way to existing products.

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