EU OKs low-dose Xarelto to prevent recurrent VTE

A lower dose formulation of Bayer and Janssen’s bloodthinner Xarelto has been approved by European regulators for preventing recurrent venous thromboembolism, expanding treatment options for patients.

VTE, a condition that covers deep vein thrombosis and pulmonary embolism, is the third most common cause of cardiovascular disease worldwide, after heart attack and stroke, killing more than 25,000 people a year in the UK alone.

The European Commission has cleared an update to the label of Xarelto (rivaroxaban), an oral Factor Xa inhibitor, to include a 10mg once daily dose for extended prevention of recurrent VTE, for patients who have already received at least six months of standard anticoagulation therapy.

The decision provides clinicians with an additional treatment option alongside the 20mg once daily dose already licensed in this indication.

"This is welcome news for clinicians across the UK, providing us with an effective, dose-specific option to reduce the risk of recurrent VTE," said Dr Alexander Cohen, principal study investigator, Guys & St Thomas’ Hospitals, Kings College London.

"In the past there has been uncertainty about how to manage ongoing anticoagulation therapy, but this announcement means we 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."

The approval is based on data from the 3,396-patient, Phase III EINSTEIN CHOICE study, which showed that both 10mg and 20mg once daily dosages of Xarelto significantly slashed the risk of recurrent VTE compared with aspirin 100mg once daily in patients who had previously completed six to 12 months of anticoagulation therapy for treatment of PE and/or symptomatic DVT.

According to Bayer, Xarelto 10mg once daily significantly reduced the relative risk of recurrent venous thromboembolism by 74 percent (absolute risk reduction of 3.2 percent), "providing superior protection compared with aspirin".

In the UK, the drug is already cleared for use to prevent stroke and systemic embolism in adults with non-valvular AF with one or more risk factors; to treat DVT and PE and prevent their recurrence in adults; to prevent VTE in adults undergoing elective hip or knee replacement surgery; and to prevent atherothrombotic events in certain adult patients.