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DewDiligence

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Re: DewDiligence post# 64616

Wednesday, 07/30/2008 2:09:37 AM

Wednesday, July 30, 2008 2:09:37 AM

Post# of 252431
JNJ Submits Rivaroxaban NDA for VTE Prevention

[Rivaroxaban is already approved in this indication in the EU, where it is being commercialized by Bayer (#msg-30972846).]

http://biz.yahoo.com/bw/080730/20080729006413.html

›Wednesday July 30, 1:00 am ET

Filing Seeks Approval For Use in Prevention of Deep Vein Thrombosis and Pulmonary Embolism in Patients Undergoing Orthopedic Surgery

RARITAN, N.J.--(BUSINESS WIRE)--Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today 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 approved 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 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 hip or knee replacement surgery are at high risk 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 blood clots occur in up to 40% of patients undergoing major orthopedic surgery who do not receive preventative care. Each year, approximately 700,000 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.

The filing was supported by data from the global RECORD (REgulation of Coagulation in major Orthopedic surgery 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.‹

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