强生（Johnson & Johnson）周一称，FDA拒绝了拜瑞妥（Xarelto）用于急性冠脉综合征患者以减少心脏病发作和中风风险的扩大应用申请。
该药由强生和拜耳合作开发。去年6月，FDA拒绝批准将Xarelto用于急性冠脉综合征患者，因为FDA的一个顾问小组对缺少的试验数据及出血风险提起了担忧。针对这一情况，强生向FDA提交了额外的数据，指明了Xarelto在已退出临床试验的患者中的临床益处及风险。强生称，正在评估由FDA发出的拒绝信函。
详细英文报道：
(Reuters) - Johnson & Johnson said health regulators denied approval to an expanded use of its blood thinner, Xarelto, to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome.
The drug, which J&J has developed in partnership with German drugmaker Bayer AG, was earlier denied approval in June for the same use, as a panel to the U.S. Food and Drug Administration raised concerns about missing trial data and bleeding risks.
In response to this, J&J submitted to the FDA additional data that showed the benefits and risks of Xarelto in patients who had withdrawn from the study.
"While we saw an increase in major bleeding, there was no increase in fatal bleeding," said Dr. Christopher Nessel, Vice President at Janssen, a unit of J&J.
Xarelto is already approved for six other uses, including reducing the risk of blood clots in patients who have had hip and knee replacement surgery, and to prevent strokes among people with a type of irregular heartbeat called atrial fibrillation.
J&J said on Monday it was evaluating the rejection letter issued by the FDA.
