Bayer's Novel Anticoagulant Rivaroxaban Submitted For U.S. Approval

�Bayer's cooperation partner Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has submitted the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for rivaroxaban (Xarelto�), a novel anticoagulant taken as one tablet, once-daily. It seeks approval for the use of rivaroxaban in the bar of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.




Rivaroxaban was invented in Bayer's Wuppertal laboratories and is being collectively developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Once marketing authorization has been granted in the U.S., rivaroxaban volition be commercialized by Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.




Rivaroxaban is the first base oral decoagulant to establish superior efficacy over the U.S. sanctioned twice-daily injectable regimen of enoxaparin, with a similar safety profile and no significant increase in major bleeding. Upon FDA approving, rivaroxaban volition be the first novel oral decoagulant introduced in the U.S. market for more than 50 years.




In accession to the FDA submission, filings ar under limited review with regulative agencies around the world. On July 24, rivaroxaban was recommended for favourable reception in Europe for the prevention of venous thromboembolism (VTE) next elective pelvis and genu replacement oR.




"We ar pleased to see rivaroxaban take an important step toward regulative approval so swiftly subsequently demonstrating unequaled success in the rich clinical trial program," aforementioned Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee, responsible for product development. "Current standards of anticoagulation therapy have limitations and new contraceptive therapies ar needed. We are now on the cusp of revolutionizing the care of patients undergoing hip and knee substitute surgery."




The NDA in the U.S. is supported by data from the RECORD clinical program, in which more than 12,500 orthopedic patients experience been investigated - the largest ever so conducted in the bar of VTE in patients undergoing knee joint or pelvic arch replacement surgical procedure. It comprised four polar Phase III clinical trials that compared rivaroxaban with enoxaparin. Rivaroxaban demonstrated superior efficacy over enoxaparin in head-to-head comparisons (RECORD1, 3 and 4), and a comparison of extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2). In all four trials, rivaroxaban and enoxaparin demonstrated similar base hit profiles including low rates of major bleeding.




Almost 50,000 patients ar planned to be evaluated in the total clinical development program which includes trials in prevention and treatment of a tolerant range of acute and chronic blood coagulation disorders. Based on the clinical evidence reported to date from over 32,000 patients (of which more than 18,000 patients take been exposed to rivaroxaban), no safety issues