Pivotal Phase III Data Showed Rivaroxaban Was Statistically Superior to Enoxaparin in Preventing Venous Thromboembolism (VTE) in Patients Following Hip Replacement Surgery
Data from the RECORD1 study show that rivaroxaban demonstrated a 70% relative risk reduction (RRR) (p less than 0.001) in total VTE when compared with enoxaparin, and an 88% RRR (p less than 0.001) in major VTE. Rivaroxaban demonstrated a similar rate of both major bleeding (0.3% and 0.1%, respectively, p=0.178) and non-major bleeding (5.8% and 5.8% p=1.000) compared to enoxaparin.
These data were released today at a press conference during the 49th Annual Meeting of the American Society of Hematology (ASH) by Dr. Bengt Eriksson, Orthopedic Surgeon at the Sahlgrenska University Hospital/Ostra, Gothenburg, Sweden, and Principal Investigator of the RECORD1 clinical trial. In addition, Dr. Eriksson will present the RECORD1 results at the major plenary session on Sunday, December 9th.
Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from the prevention and/or treatment of blood clots. Rivaroxaban works at a pivotal stage in the coagulation process to directly inhibit the enzyme Factor Xa.
The RECORD1 (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial evaluated the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total hip replacement surgery. The duration of thromboprophylaxis in both treatment groups was five weeks. The primary endpoint was total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality) and the main secondary endpoint was major VTE (composite of proximal deep vein thrombosis, non-fatal pulmonary embolism and VTE-related death).
Further Phase III data evaluating rivaroxaban in major orthopedic surgery - including results from the RECORD2 and RECORD3 clinical trials - will be presented during oral sessions on Monday, December 10th at the ASH meeting in Atlanta. The corresponding abstracts (#307 and #308) may be viewed online at the ASH website at www.hematology.org/meetings/abstracts.cfm.
To date, rivaroxaban is the most studied oral, direct Factor Xa inhibitor in clinical development. More than 20,000 patients have been evaluated in the completed Phase II programs and enrolled thus far in the Phase III programs. Almost 50,000 patients are expected to be evaluated in the total clinical development program.
Bayer HealthCare submitted a regulatory filing to the European Agency for the Evaluation of Medicinal Products (EMEA) at the end of October 2007 for approval to market rivaroxaban in the EU for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs. Upon regulatory approval, rivaroxaban will be commercialized in Europe by Bayer Schering Pharma. A filing for rivaroxaban for a similar indication in the United States is planned in 2008, where upon approval, it will be commercialized by Scios Inc. and Ortho-McNeil, Inc., both of which are wholly-owned subsidiaries of Johnson & Johnson.
Johnson & Johnson Pharmaceutical Research and Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from J&JPRD's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. J&JPRD does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
For more information on rivaroxaban:
Johnson & Johnson Pharmaceutical Research
& Development, L.L.C.
Media: Ernie Knewitz
Steven Cooper â?? onsite at ASH
Posted: December 2007
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