Bayer’s Xarelto recommended for extended prevention of venous thromboembolism

Bayer has announced that its oral Factor Xa inhibitor Xarelto has been recommended for European approval for the extended prevention of recurrent venous thromboembolism.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion to update the label for Xarelto to include a once-daily dose for the extended prevention of recurrent venous thromboembolism, applying to any patients who have already received at least six months of standard anticoagulation therapy.

This decision was based on positive data from the Phase III EINSTEIN CHOICE study, which showed that both 10 mg and 20 mg once-daily dosages of Xarelto significantly reduced the risk of recurrent venous thromboembolism compared with aspirin.

Following this recommendation from the CHMP, a final decision from the European Commission is expected in November.

Dr Joerg Moeller, member of the executive committee of Bayer's pharmaceutical division and head of development, said: "Today's positive CHMP opinion takes us one step closer to providing physicians with an additional therapeutic option enabling them to select the extended treatment that best suits the benefit-risk-assessment of the individual patient."

Xarelto was developed in partnership with Janssen and has been approved in more than 130 countries across all indications.

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