Posted by Michael Wonder on 30 Oct 2017
Bayer receives FDA approval for Xarelto 10 mg once daily for the extended treatment of venous thromboembolism
30 October 2017 - Rivaroxaban (Xarelto) 10 mg once daily significantly reduces the risk of recurrent venous thromboembolism compared with aspirin 100 mg once daily following at least six months of standard anticoagulation therapy / FDA approval based on data from the EINSTEIN CHOICE study.
Bayer AG and its development partner Janssen advise that the U.S. 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 in the USA.
This label update applies to patients at a continued risk of deep vein thrombosis and/or pulmonary embolism 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.
