Xarelto is a prescription blood thinner manufactured by Bayer. First approved by the Food and Drug Administration in 2011 for the treatment of deep vein thrombosis and pulmonary embolism in people having knee or hip replacement surgery. Later in 2011, the FDA approved Xarelto for treatment of afib, also known as nonvalvular atrial fibrillation. The drug has since been embroiled in lawsuits claiming that it can lead to excessive bleeding, leading to death in some cases.
However, Bayer is still seeking approval for Xarelto as a treatment for other conditions. Most recently, it failed to gain approval to widen use, as Reuters reports.
Co-manufacturers Bayer and Johnson & Johnson were seeking to widen the use of conditions that their blood-thinning drug, Xarelto are approved to treat.
The condition which they sought approval to use their blockbuster blood thinner to treat was reducing the risk of blood clot in a specific group of high-risk patients. The patients in the study had been admitted to the hospital for conditions that increased the risk of venous thromboembolism. These conditions included heart failure, acute respiratory disease, ischemic stroke, and certain infections.
In the study, Xarelto did not appear to reduce the risk of venous thromboembolism.
This is a turn of fortunes of a sort for Bayer, which had most recently won approval for use of Xarelto in atherosclerosis patients.
Bayer has the marketing rights for Xarelto outside the United States. Partner Johnson & Johnson sell the drug in the U.S.
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