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FDA Denies Approval for Expanded Use of Xarelto (Rivaroxaban) in ACS
For the second time, the FDA has refused to approve the expanded use of the blood thinner Xarelto (rivaroxaban) to reduce the risk of heart attacks and stroke in patients with acute coronary syndrome (ACS), according to a Reuters report.
The drug was turned down in June for the same indication when the agency expressed concerns regarding missing trial data and the risk of bleeding.
In response, the drug’s developer, Johnson & Johnson, submitted data related to patients who had withdrawn from a pivotal clinical trial of Xarelto. The new information was also considered insufficient.
J&J said it is reviewing the new rejection letter.
Xarelto is approved for six other indications, including reducing the risk of blood clots in the legs and lungs of patients who have had hip- or knee-replacement surgery, and preventing strokes in patients with atrial fibrillation.
Source: Reuters; March 4, 2013.