The European Medicines Agency paved the way for approval for rivaroxaban (Xarelto, Bayer/Johnson & Johnson) for treatment of adults with pulmonary embolism (PE) and the prevention of recurrent PE in adults.
On Oct. 18, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorization for Xarelto 15 and 20 mg strengths. The oral direct factor Xa inhibitor already was approved in Europe for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (AF) with one or more risk factors; for treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and PE following an acute DVT in adults; and for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery.
The committee adopted the following new contraindications:
- Lesion or condition at significant risk of major bleeding, such as current or recent gastrointestinal ulceration;
- Presence of malignant neoplasms at high risk of bleeding;
- Recent brain or spinal injury;
- Recent brain, spinal or ophthalmic surgery;
- Recent intracranial hemorrhage;
- Known or suspected esophageal varices;
- Arteriovenous malformations;
- Vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; and
- Concomitant treatment with any other anticoagulant agent, for instance, unfractionated heparin, low molecular weight heparins, heparin derivatives, oral anticoagulants such as warfarin and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), except under the circumstances of switching therapy to or from rivaroxaban or when unfractionated heparin is given at doses necessary to maintain a patent central venous or arterial catheter.
The European Commission is expected to issue a final opinion by the end of 2012.