Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) issued complete response letters (CRLs) regarding the supplemental New Drug Applications for the oral anticoagulant Xarelto (rivaroxaban) 2.5mg twice daily (BID) in combination with standard antiplatelet therapy to reduce the risk of thrombotic cardiovascular events and stent thrombosis in patients with Acute Coronary Syndrome (ACS).
“We are disappointed with the outcome of the review and together with our cooperation partner Janssen Research & Development LLC remain committed to providing ACS patients in the U.S. with additional protection against stent thrombosis and life-threatening thrombotic cardiovascular events,” said Dr. Jörg Möller, member of the Bayer HealthCare Executive Committee and head of global development.
In May 2013, the European Commission approved Xarelto for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an ACS in adult patients with elevated cardiac biomarkers at a dose of 2.5mg twice daily (BID) co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
Xarelto is approved for five indications across seven distinct areas of use, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other novel oral anticoagulant.
Date: February 14, 2014
Source: Bayer HealthCare
Filed Under: Drug Discovery