Janssen Pharmaceuticals announced FDA approval of Xarelto (rivaroxaban) tablets for the prevention of deep vein thrombosis (DVT) that may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.
The researchers found that a composite outcome of symptomatic venous thromboembolism or death due to venous thromboembolism occurred in 0.83% of patients in the rivaroxaban group and in 1.10% in the placebo group (hazard ratio, 0.76; 95% confidence interval, 0.52 to 1.09; P=0.14).
Drugs in the Pipeline
The NDA submission is supported by data from the phase 3 EINSTEIN-Jr and UNIVERSE trials in pediatric patients, along with adequate and well-controlled studies in adults.
A recent report highlights the importance of using rivaroxaban cautiously in morbidly obese.
Novel oral anticoagulants, that do not require the laboratory monitoring associated with warfarin therapy, may alter the landscape of venous thromboembolism treatment and stroke prevention in atrial fibrillation, according to a study presented at the 52nd American Society of Hematology Meeting and Exposition.
Oral anticoagulation with rivaroxaban for stroke prevention in atrial fibrillation (AF) patients resulted in low rates of bleeding and stroke, researchers presented at the European Society of Cardiology Congress 2015.
A case study reports on two patients that experienced severe liver injury onset during treatment with the oral anticoagulant rivaroxaban.
Drugs in the Pipeline
Janssen and Bayer presented the first results from their comprehensive research program, CALLISTO, which evaluated rivaroxaban for the treatment and prevention of venous thromboembolism (VTE) in patients with active cancer, at the 2015 American Society of Hematology (ASH) Annual Meeting.
A once daily oral dose of rivaroxaban (Xarelto) significantly lowers the risk of intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF) at moderate to high risk of stroke.
Currently, the prescribing information recommends 20mg once daily with an evening meal for the AF indication, and 15mg twice daily with food for 21 days, followed by 20mg once daily with food for the remainder of treatment for the DVT/PE indications.