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Clexane(R)/Lovenox(R) Approved in Japan
Date:1/28/2008

PARIS, January 28 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the anticoagulant Clexane(R) (enoxaparin sodium injection) has been approved for marketing in Japan by the Ministry of Health, Labour and Welfare for the prevention of venous thromboembolism (VTE) in patients undergoing orthopaedic surgery of the lower limbs such as total hip replacement, total knee replacement and hip fracture surgery.

Venous thromboembolism is a frequent and preventable complication among patients hospitalized for orthopaedic surgery. Deep vein thrombosis (DVT) and pulmonary embolism are common manifestations of VTE and can significantly impact morbidity and mortality in surgical patients. The Japanese VTE guidelines state that, without prophylaxis, between 27% and 50% of orthopaedic surgery patients may suffer from deep vein thrombosis. Among the hospitalised patients at risk for VTE, 64% are those undergoing surgery(1).

"In Japan, Clexane(R) is expected to greatly contribute to the prevention of venous thromboembolism and fulfil an important medical need for patients undergoing orthopaedic surgery" said Hanspeter Spek, Executive Vice-President Pharmaceutical Operations of sanofi-aventis. "Clexane(R)'s approval illustrates the commitment of sanofi-aventis to bring new life saving drugs to patients in Japan, where further clinical trials are being conducted with Clexane(R) to extend its use to abdominal surgery patients who are at risk for venous thromboembolic complications" he added.

Outside Japan with over 200 million patients treated in more than 100 countries, Clexane(R) / Lovenox(R) (enoxaparin sodium) is the most extensively studied and most widely used low-molecular-weight heparin in the world. In venous thrombosis, Clexane(R) / Lovenox(R) is recommended by international guidelines not only in orthopaedic and general surgical patients at high and moderate risk of VTE, but also for acutely ill medical patients, and is an important tre
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