EU approves 10 mg once daily dose of Xarelto to prevent recurrent VTE.- Bayer + Janssen.

Bayer AG and its development partner Janssen Pharmaceuticals, Inc. announced that the European Commission (EC) has approved an update to the label of its oral Factor Xa inhibitor Xarelto (rivaroxaban) to include a 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism (VTE). This label update applies to patients who have already received at least six months of standard anticoagulation therapy, and provides clinicians with an additional treatment option alongside the 20 mg once daily dose already licensed in this indication.

This approval provides an effective, dose-specific option to reduce the risk of recurrent VTE. In the past there has been uncertainty about how to manage ongoing anticoagulation therapy, but the approval means physicians can confidently treat high risk patients and reduce the number of VTE-related deaths, while improving the lives of those who live under the constant threat of a recurrent VTE. VTE, which includes pulmonary embolism (PE), a clot that travels to the lung, and deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs), has a significant global impact and is the third most common cause of cardiovascular disease worldwide, after heart attack and stroke.

DVT affects as many as one in every 1,000 people in the UK, while PE affects 86 in every 100,000, and each year more than 25,000 people in the UK die from VTE. The current treatment recommendation for the prevention of recurrent VTE is anticoagulation therapy for three months or longer, depending on the balance between the risk of recurrent VTE and the risk of bleeding. However, the risk of patients with unprovoked VTE or with ongoing risk factors experiencing a second event is up to 10% in the first year if treatment is stopped.