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Bayer seeks ACS approval for Xarelto

Bayer has said it intends to file Xarelto (rivaroxaban) for marketing approval in the treatment of patients with acute coronary syndrome (ACS)

Bayer has said it intends to file its blood thinner Xarelto (rivaroxaban) for marketing approval in the treatment of patients with acute coronary syndrome (ACS) by the end of 2011.

The announcement comes after a phase III trial that demonstrated that Xarelto plus standard therapy significantly reduced the rate of events for the study's primary endpoint of cardiovascular death, myocardial infarction and stroke in patients with ACS.

However, Xarelto also demonstrated a significant increase in major bleeding events not associated with coronary artery bypass graft surgery – the primary safety endpoint of the trial.

Xarelto, which Bayer is co-developing with Johnson & Johnson, is already approved for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

The US Food and Drug Administration (FDA) recently recommended the drug for use in stroke prevention in patients with the heart condition nonvalvular atrial fibrillation.

3rd October 2011


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