强生（JNJ）和拜耳（Bayer）2月14日表示，FDA已拒绝了抗凝血剂拜瑞妥（Xarelto）用于急性冠脉综合征（ACS）的新适应症申请。这已是FDA第三次拒绝批准Xarelto用于ACS适应症。

强生最初于2011年底提交了Xarelto用于ACS治疗的适应症申请，但遭FDA拒绝，FDA称疗效数据并没有强大到足以支持该适应症的获批。随后，强生提交了额外的数据，但遭FDA再度拒绝。

在强生第3次提交Xarelto ACS适应症申请后，FDA内部最新审查表明，该机构对强生分析相关临床数据的方法持怀疑态度，并表示没有令人信服的证据来证明Xarelto能够提供显著的临床利益或填补未获满足的医疗需求，因为市场上还有其他药物。而FDA顾问委员会于2014年1月举行会议并投票表决，认为不应批准Xarelto用于ACS适应症，该委员会认为，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，是不可取的。

当被问及FDA是否已要求开展新的临床试验或其他数据时，强生发言人Kristina Chang拒绝置评。

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）。

英文原文：

(Reuters) - U.S. health regulators have declined to approve proposed wider uses of Bayer AG and Johnson & Johnson's lucrative blood clot preventer Xarelto, the drugmakers said on Friday.

The companies had sought approval from the U.S. Food and Drug Administration (FDA) to market the blockbuster pill for prevention of new heart attacks and strokes, and death, in patients with heart disease, and also to prevent clogging of heart stents.

Xarelto's biggest current approved use is to prevent blood clots and strokes in patients with an irregular heartbeat called atrial fibrillation. The condition occurs mainly in the elderly.

An advisory panel to the FDA concluded in January that Xarelto should not be approved to prevent new heart attacks or strokes, a use referred to as secondary prevention. The medicine is co-marketed by J&J and Bayer.

Johnson & Johnson spokeswoman Kristina Chang declined to comment when asked if the FDA, in its rejection, had asked for new clinical trials to be conducted for the requested new uses or asked for other information.

"We are not disclosing the details because we still are evaluating the contents and our next steps," Chang said.

Shares of J&J were up 0.3 percent in premarket trading, while shares of Bayer rose 0.71 percent in Germany.

关键词： 强生 拜耳 拜瑞妥 Xarelto 急性冠脉综合征

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