Bayer's Xarelto gains EU clearance for secondary prevention after ACS

German chemical and pharma group Bayer (BAYN: DE) says that its novel oral anticoagulant Xarelto (rivaroxaban) has been approved by the European Commission for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an acute coronary syndrome (ACS) in adult patients with elevated cardiac biomarkers at a dose of 2.5mg twice-daily (BID) in combination with standard antiplatelet therapy.

This approval, which follows a recent positive recommendation from the European Medicines Agency’s advisory committee (The Pharma Letter March 25), makes rivaroxaban the only novel oral anticoagulant approved to protect patients with elevated cardiac biomarkers following an ACS event, says Bayer Healthcare. The drug is partnered with health care giant Johnson & Johnson (NYSEL JNJ) in the USA.

Xarelto, which is already approved and marketed for several indications (the most important being stroke prevention in patients with atrial fibrillation), generated sales of 322 million euros ($416.4 million) in 2012, and Bayer has forecast peak sales of 2 billion euros for the drug. However, there was a setback earlier this year, when the US Food and Drug Administration issued a second complete response letter regarding its supplemental New Drug Administration (sNDA) for Xarelto for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (The Pharma Letter March 5).