The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has recommended the use of the anticoagulant rivaroxaban (Bayer, Xarelto) to prevent stroke and systemic embolism in non-valvular atrial fibrillation (AF) patients and to treat deep vein thrombosis (DVT). The two positive opinions adopted Sept. 22 come on the heels of the FDA’s Cardiovascular and Renal Drug Committee's recommendation that the drug be approved for use in non-valvular AF patients.
If cleared, rivaroxaban would be the first anticoagulant approved for three indications in the European Union states.
The three scenarios are:
- 10 mg dose of the drug to prevent venous thromboembolism (VTE) in patients undergoing hip and knee replacement surgery;
- 15 mg and 20 mg tablets to prevent stroke and systemic embolism in adult non-valvular AF patients with one or more risk factor (i.e., congestive heart failure or hypertension); and
- 15 mg and 20 mg doses to prevent DVT and recurrent DVT and pulmonary embolism following acute DVT.
EMA said that conditions for product usage will be described and updated in a European public assessment report.
“The recommendation by the CHMP to approve rivaroxaban in these two additional indications is a significant milestone for our company,” Kemal Malik, MD, chief medical officer of Bayer Healthcare, said in a statement. “We expect that we will soon be able to provide patients and physicians in Europe with an effective alternative for the prevention of strokes in patients with atrial fibrillation as well as a new, convenient single drug approach to the treatment of DVT.”
The EMA committee recommendation for rivaroxaban was based on results of the ROCKET AF trial. Additionally, the recommendation of the treatment of DVT was based on results of the EINSTEIN-DVT trial presented at the 2010 European Society of Cardiology congress.