Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for marketing authorization to treat patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as to prevent recurrent venous thromboembolism (VTE).
“Venous blood clots are associated with a high risk of serious complications and the current standard of care for treating these patients involves multiple medications,” said Dr. Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development. “With this submission, Xarelto is one step closer to being available to provide patients and physicians in Japan with a single-drug treatment option from the moment of diagnosis through to the completion of therapy.”
The submission to the MHLW is based on the results of three global clinical trials within the pivotal EINSTEIN clinical trial program, and is supported by the J-EINSTEIN studies (J-EINSTEIN DVT and J-EINSTEIN PE), which were run entirely in Japan. The EINSTEIN DVT and EINSTEIN PE studies evaluated rivaroxaban alone versus the dual-drug regimen of low molecular weight heparin (LMWH) and a vitamin K antagonist (VKA) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) respectively, and in the prevention of recurrent DVT and PE. The EINSTEIN Extension study compared rivaroxaban with placebo for the long term prevention of recurrent symptomatic DVT and PE in patients who previously completed 6 or 12 months of anticoagulation treatment with either VKA or rivaroxaban.
Pooled data of over 8,000 patients reaffirmed that the single-drug approach with Xarelto is effective in both the treatment and subsequent prevention of recurrent DVT and PE, with an overall safety profile comparable to the traditional dual-drug regimen. In addition, compared to the traditional dual-drug approach of injectable LMWH followed by a VKA, Xarelto significantly reduced the rate of major bleeding events by 46%, including the risk of fatal bleeding, whilst offering an improved benefit-risk profile regardless of patient age, frailty, gender, weight or renal function.
Results from the three global studies have been published in the New England Journal of Medicine. Results of the J-EINSTEIN studies are planned to be presented at an upcoming scientific meeting.
Xarelto has been approved as the only oral single-drug approach for the treatment of DVT and PE as well as for the prevention of recurrent DVT and PE in more than 100 countries worldwide, including Europe and the Unites States.
Date: May 28, 2014
Source: Bayer HealthCare