Rivaroxaban Approved in Europe for AF and DVT Treatment

December 19, 2011

December 19, 2011 (London, United Kingdom) The factor Xa oral anticoagulant rivaroxaban (Xarelto, Bayer/Johnson & Johnson) has been approved in the European Union for the prevention of nonvalvular AF-related stroke and systemic embolism and for the treatment of deep venous thrombosis (DVT) [1].

The AF indication is based on the ROCKET-AF trial. The DVT indication is based on the EINSTEIN program of trials. The recommended dose of rivaroxaban is 20 mg once daily or 15 mg once daily for patients with moderate to severe renal impairment.

In the UK, rivaroxaban is being made available straight away at a retail list price of £2.10 per 20-mg tablet across both indications. Bayer reports that AF affects approximately 750 000 people in the UK and that one in every 1000 people is affected by venous thrombosis each year.

Rivaroxaban is already available in Europe for the prevention of venous thromboembolism in patients undergoing elective total hip- or knee-replacement surgery. Bayer says it is the first of the new oral anticoagulants to be approved for all three indications across all 27 EU member states.

It is, however, the second of the new oral anticoagulants to reach the market for the AF indication--after the direct thrombin inhibitor dabigatran (Pradaxa, Boehringer Ingelheim), which was approved earlier this year.

Rivaroxaban was also recently approved in the US for the AF indication.

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