May 23, 2012: A medical reviewer of Food and Drug Administration (FDA) recommended the agency to approve the use of anti-clotting drug Xarelto from Johnson & Johnson and Bayer AG for treating patients suffering from heart problem called as acute coronary syndrome.

It is to be noted that the drug has already been approved last year to prevent strokes in patients suffering from a heart-rhythm disorder known as atrial fibrillation and also for short-term use by patients undergoing knee or hip replacement surgery.

Now, the companies are seeking the approval of medical experts to market the drug for use in treating acute coronary syndrome. Acute coronary syndrome disorder occurs due to blood clot in artery and results in reduction of blood flow to the heart. As the drug effectively breaks down the blood clot that develops inside coronary artery and improves the blood flow to the heart, it is considered as a good medicine for treating acute coronary syndrome. In order to decide on whether to approve the drug for use or not, Food and Drug Administration advisory panel will be reviewing the drug Xarelto Today.

Moreover, a panel including non-FDA medical experts has been asked to vote on whether to approve the drug for use in treating coronary syndrome patients or not and even to discuss several issues related to its use including whether the agency’s most severe boxed warning about bleeding risks should be carried by the drug or not.

As part of the preparation for Today’s meeting, FDA has released its review of the drug Xarelto. One medical reviewer of the agency has recommended approval of Xarelto for reducing the cardiovascular events risks in patients suffering from acute coronary syndrome. Contrary to this, the same medical reviewer has also declared that the drug shouldn’t be used for the patients with the prior stroke history. Also, the reviewer has recommended for the placing of the boxed warning on the drug to warn about bleeding risks in certain patient groups. It is assumed that the reviewer’s recommendation has increased the chances of the approval of Xarelto drug use for patients with coronary syndrome disorder by the FDA advisory panel.

To get the drug approved for use to treat coronary syndrome patients, the companies have submitted the clinical study conducted over 15,000 patients suffering from acute coronary syndrome. As per this study, the patients were randomised to be treated with one of two doses of a placebo medicine or Xarelto. The other medicines usually used to treat ACS including low-dose Aspirin and Plavix were used by all the patients. Patients were examined, on an average, for 13 months. Overall, the findings of the study reveal that the patients falling in the Xarelto group had a reduction in the risk of combination of cardiovascular death, heart attacks or stroke by 16% in comparison with those who didn’t receive the medicine.

As per FDA, the benefit was mostly among the lower 2.5-miligram dose of the drug that the companies are asking for approval to use in ACS patients. The FDA reviewers said that the benefit of Xarelto was driven by a reduction in heart problem related death; albeit there was an increased risk of bleeding that includes fatal bleeding as well.  However, the reduction in heart problem related deaths overshadowed the bleeding risk.

J&J said that the bleeding-related strokes were higher among patients, but also said that the fatal bleeding rates were similar. Out of 5,115 patients, six of them received 2.5 milligrams of Xarelto and still died from bleeding complication, whereas nine patients out of 5,125 who did not receive the drug also died from a bleeding related complication.

Although the Xarelto review of FDA was overall positive, the agency was worried about the missing data including data of 1000 patients who were considered as having “unknown vital status” at the end of the study. Nearly 2,400 patients or 15% patients prematurely stopped participating in the study.

Thus, the approval of Xarelto drug use for treating patients having heart-related problem such as acute coronary syndrome completely depends on the Today meeting of the FDA. However, the companies hope that the drug will get approved for use to treat coronary syndrome patients.

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