EU Approves Xarelto for Secondary Prevention after an ACS

May 24, 2013

BERLIN, Germany — The European Commission has given its approval to the oral factor Xa inhibitor rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals) for secondary prevention in adult patients who have had biomarker-confirmed acute coronary syndrome (ACS), Bayer announced today [1]. The indication is for 2.5-mg twice daily in combination with standard antiplatelet therapy.

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended the rivaroxaban approval for ACS in March, based largely on the ATLAS ACS 2 TIMI 51 trial, which randomized >15 000 patients. In it, the 2.5-mg twice-daily dose was associated with a reduction in overall and cardiovascular mortality vs placebo, despite an increased risk of bleeding and intracranial hemorrhage (ICH). The 5-mg dose also tested in the trial, however, was associated with an increased bleeding risk that outweighed the drug's benefits.

The ACS indication has often been more of a challenge for the new generation of oral anticoagulants in their quests for approval by US and European regulators, compared with other indications for the drugs. Also in March, for example, the US FDA put off its much-anticipated ruling on rivaroxaban for ACS secondary prevention while it asked the company for more safety data.

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