May 24th, 2013

Rivaroxaban Gains Approval in Europe for ACS Indication

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive an ACS indication.

The approval is based on data from the pivotal ATLAS ACS 2-TIMI 51 trial. In the United States, where Xarelto is marketed by Johnson & Johnson, the FDA has twice rejected an ACS indication for rivaroxaban.

The new indication joins the already-approved indications for higher doses of rivaroxaban for the prevention of venous thromboembolism in patients undergoing elective hip or knee replacement surgery, for the treatment of (and prevention of recurrent) deep vein thrombosis and pulmonary embolism, and for stroke prevention in patients with atrial fibrillation.

“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk. In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk,” said C. Michael Gibson, the Principal Investigator of the ATLAS ACS2-TIMI 51 trial, in a Bayer press release. “This approval marks an important shift in the way we deliver protection to patients who are at risk of a secondary atherothrombotic event.”


One Response to “Rivaroxaban Gains Approval in Europe for ACS Indication”

  1. Jean-Pierre Usdin, MD says:

    A backward looking remark from a backward looking cardiologist!

    I wonder if the important numbers of tablets’ dosage will not be a big problem in the daily practice.

    Let’s make the inventory:
    tablets of 2.5 mg twice a day (ACS)
    tablets of 10 mg once a day (DVT Prophylaxis)
    tablets of 15 mg once (prevention of thrombo embolism in non valvular atrial fibrillation -TE in NV FA- if mild renal impairment) OR TWICE: acute phase of phlebitis (DVT) or pulmonary embolism (PE) .
    20 mg: chronic treatment of DVT (or PE) BUT ALSO preventive treatment of TE in NV AF…

    I know it is “an incorrect speech on pharmacological point of view!”
    But imagine the disappointment of GP or Cardiologist and do not forget Emergency colleagues (they definitely do not like the New Oral Anticoagulants- NACO- you already know that!) if the patient is not able to indicate the reason of his (her) NACO’s treatment

    It was easier with AVK, is not it?…