The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for a new strength of the anticoagulant rivaroxaban for the prevention of atherothrombotic events in adults after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.
The positive opinion in the EU comes just weeks after the FDA turned away a supplemental New Drug Application for rivaroxaban (Xarelto, Bayer HealthCare/Janssen Pharmaceuticals) for the reduction of the risk of cardiovascular events in patients with ACS.
CHMP issued a positive opinion recommending a variation to the terms for 2.5mg rivaroxaban co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel (Plavix, Bristol-Myers Squibb), or ticlopidine for adult patients. It said that detailed conditions for its use will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report.
The variation to the marketing authorization still must be granted by the European Commission.
The 10mg dose has already been approved in the EU for prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery; and 15mg and 20mg doses for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted in 2012 against recommending the drugs’s approval for ACS patients, citing concerns over missing data in the ATLAS ACS TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) trial. The study evaluated the efficacy of rivaroxaban compared to placebo in preventing cardiovascular death, MI or stroke in patients after an ACS.