Bayer's cooperation partner Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has submitted the new drug application (NDA) to the US 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 prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Rivaroxaban is first oral anticoagulant to achieve superior efficacy over the twice-daily injection of enoxaparin, while maintaining low rates of major bleeding or no evidence of safety issues attributable to rivaroxaban after long-term exposure
Rivaroxaban was invented in Bayer's Wuppertal Laboratories and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, LLC. Once marketing authorization has been granted in US, rivaroxaban will be commercialized by Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Rivaroxaban is the first oral anticoagulant to demonstrate superior efficacy over the US approved twice-daily injectable regimen of enoxaparin, with a similar safety profile and no significant increase in major bleeding. Upon FDA approval, rivaroxaban will be the first novel oral anticoagulant introduced in the US market for more than 50 years.
In addition to the FDA submission, filings are under review with regulatory agencies around the world. On July 24, rivaroxaban was recommended for approval in Europe for the prevention of Venous Thrombo Embolism (VTE) following elective hip and knee replacement surgery.
"We are pleased to see rivaroxaban take an important step toward regulatory approval so swiftly after demonstrating unparalleled success in the robust clinical trial program," said Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee, responsible for product development. "Current standards of anticoagulation therapy have limitations and new preventative therapies are needed. We are now on the cusp of revolutionizing the care of patients undergoing hip and knee replacement surgery."
The NDA in US is supported by data from the Record clinical program, in which more than 12,500 orthopaedic patients have been investigated - the largest ever conducted in the prevention of VTE in patients undergoing knee or hip replacement surgery. It comprised four pivotal phase-3 clinical trials that compared rivaroxaban with enoxaparin Rivaroxaban demonstrated superior efficacy over enoxaparin in head-to-head comparisons (Record-1, 3 and 4), and a comparison of extended-duration (five weeks) rivaroxaban with short-duration (two weeks) enoxaparin (Record-2). In all four trials, rivaroxaban and enoxaparin demonstrated similar safety profiles including low rates of major bleeding.
In US, more than 9,00,000 people suffer from VTE events annually, and 3,00,000 Americans die from VTE every year. Each year, approximately 7,00,000 Americans elect to have hip and knee replacement surgeries, and a blood clot is the most common cause of re-hospitalization for this patient group.
Bayer estimates the global peak sales potential of rivaroxaban for all indications to exceed EUR 2 billion.