�Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.
In 2005, J&JPRD entered into an agreement with Bayer HealthCare AG to jointly develop rivaroxaban. If sanctioned by the FDA, Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the U.S. Bayer HealthCare holds marketing rights in countries outside the U.S.
Venous blood clots, also known as venous thromboembolism (VTE), include DVT - a blood clog in a large vein, usually in the legs - and PE - a blood clot that has travelled to the lungs - both of which are life-threatening just often preventable complications following major orthopedical surgery. Annually in the U.S., more than 900,000 mass suffer from VTE events, and three hundred,000 individuals die from VTE. Patients undergoing hip or knee joint replacement surgery are at high danger for VTE because the large veins of the leg that carry blood back to the heart are significantly damaged during these procedures. In fact, venous rip clots occur in up to 40% of patients undergoing major orthopedic operating room who do not receive preventative charge. Each year, approximately 700,000 Americans elect to have rosehip and knee replacement surgeries, and a blood clabber is the most common cause of re-hospitalization for this patient group.
The filing was supported by data from the world-wide RECORD (REgulation of Coagulation in major Orthopedic oR reducing the Risk of DVT and PE) clinical trial program. The RECORD program involved more than 12,500 patients in four studies and compared rivaroxaban to injected enoxaparin, for the prevention of total VTE in patients undergoing either total knee or hip replacement surgery.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a wholly-owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health attention products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug breakthrough and do drugs development in a variety show of therapeutical areas, including CNS, Internal Medicine and Oncology, to address unmet medical of necessity worldwide. More information tin can be institute at hTTP://www.jnjpharmarnd.com.
This press tone ending contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on stream expectations of future events. If underlying assumptions show inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as stake rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new production development, including obtaining regulative approvals; domestic and alien health maintenance reforms and governmental pentateuch and regulations; and trends toward health care price containment. A further list and description of these risks, uncertainties and other factors posterior be institute in Exhibit 99 of Johnson & Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are usable online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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