Bayer AG and its development partner Janssen Research & Development, LLC advise that the U.S. Food and Drug Administration (FDA) has approved a label update for their oral Factor Xa inhibitor Xarelto® (rivaroxaban) to include a 10 mg once daily dose for the extended treatment of recurrent venous thromboembolism (VTE) in the USA.
This label update applies to patients at a continued risk of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) who have already received at least six months of standard anticoagulation therapy. It provides physicians with an opportunity to strengthen the treatment paradigm of these patients from no treatment or aspirin to rivaroxaban 10 mg.
“Patients who have previously suffered a VTE are often at increased risk of experiencing another event if anticoagulant treatment is stopped,” said Dr Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “The FDA approval of the 10 mg dose provides physicians with an additional therapeutic option enabling them to continue the extended treatment with the regimen that best suits the benefit-risk-assessment of the individual patient.”
The European Commission already approved an update to the label for Xarelto in the EU at October 19th.
VTE, which includes pulmonary embolism, a clot that travels to the lung, and deep vein thrombosis, a blood clot in a deep vein (often in the legs), has a significant global impact and after heart attack and stroke, is the third most common cause of cardiovascular death worldwide. The current treatment recommendation for the prevention of recurrent venous thromboembolism is anticoagulation therapy for three months or longer, depending on the balance between the risk of recurrent VTE and the risk of bleeding.
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