Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application To FDA For Rivaroxaban
February 6th, 2010Johnson & Johnson Pharmaceutical Delving & Development, L.L.C. (J&JPRD) announced that it has submitted a New Drug Application to the U.S. Eatables and Opiate Administration (FDA) with a view rivaroxaban, an investigational, oral, in days gone by-ordinary anticoagulant for the halting of mystical trace 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 approved by the FDA, Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., at one’s desire deal in 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), categorize DVT - a blood clot in a large vein, usually in the legs - and PE - a blood clot that has traveled to the lungs - both of which are life-threatening but often preventable complications following major orthopedic surgery. Annually in the U.S., more than 900,000 people suffer from VTE events, and 300,000 individuals die from VTE. Patients undergoing hep or knee replacement surgery are at high jeopardize in the course of VTE because the magnanimous veins of the ramshackle that carry blood back to the heart are significantly damaged during these procedures. In experience, venous blood clots occur in up to 40% of patients undergoing vital orthopedic surgery who do not acquire preventative care. Each year, roughly 700,000 Americans elect to have hip and knee replacement surgeries, and a blood clot is the most common cause of re-hospitalization over the extent of this sufferer society.
The filing was supported by details from the global RECORD (REgulation of Coagulation in prime Orthopedic surgery reducing the Chance of DVT and PE) clinical trial program. The REGISTER program involved more than 12,500 patients in four studies and compared rivaroxaban to injected enoxaparin, for the prevention of add up VTE in patients undergoing either total knee or perceptive replacement surgery.
Johnson & Johnson Pharmaceutical Research & Progress, L.L.C.
Johnson & Johnson Pharmaceutical Investigate & Development, L.L.C. (J&JPRD) is a wholly-owned subsidiary of Johnson & Johnson, the world’s most broadly based organizer of robustness care products. J&JPRD is headquartered in Raritan, N.J., and has facilities fully Europe, the Collective States and Asia. J&JPRD is leveraging pharmaceutical development and drug improvement in a medley of therapeutical areas, including CNS, Internal Medicament and Oncology, to address unmet medical needs worldwide. More information can be establish at http://www.jnjpharmarnd.com.
This press release contains “forward-looking statements” as defined in the Seclusive Securities Legal remedy Reform Act of 1995. These statements are based on coeval expectations of future events. If underlying assumptions prove wrong or unknown risks or uncertainties form, actual results could vary palpably from the Company’s expectations and projections. Risks and uncertainties count widespread industry conditions and striving; economic conditions, such as charge fee and currency exchange merit fluctuations; technological advances and patents attained by competitors; challenges essential in green yield development, including obtaining regulatory approvals; domestic and foreign health take responsibility for reforms and governmental laws and regulations; and trends toward health punctiliousness payment containment. A further roster and report of these risks, uncertainties and other factors can be establish in Exhibit 99 of Johnson & Johnson & Johnson’s Annual Recount on Custom 10-K for the monetary year ended December 30, 2007. Copies of this Propriety 10-K, as well as subsequent filings, are nearby online at http://www.sec.gov, http://www.jnj.com or on entreat from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a conclude of new dirt or future events or developments.
Johnson & Johnson Pharmaceutical Up on & Development, L.L.C.