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Title: FDA Approves New Indication for Arixtra (Fondaparinux Sodium), Extended Prophylaxis of Deep Venous Thrombosis in Patients Undergoing Hip Fracture Surgery

"FDA Approves New Indication for Arixtra (Fondaparinux Sodium), Extended Prophylaxis of Deep Venous Thrombosis in Patients Undergoing Hip Fracture Surgery"

PARIS, FRANCE -- June 18, 2003 -- Sanofi-Synthelabo and Organon announced today that Arixtra® (fondaparinux sodium) has been approved by the U.S. Food and Drug Administration (FDA) for a new indication: "Prophylaxis of deep venous thrombosis, which may lead to pulmonary embolism, in patients undergoing hip fracture surgery, including extended prophylaxis." Arixtra is already indicated in the United States for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism: - in patients undergoing hip fracture surgery; - in patients undergoing hip replacement surgery; - in patients undergoing knee replacement surgery. The file for this new indication for Arixtra was submitted to the FDA on December 17, 2002 and was granted a six-month priority review in March 2003. This is the second time that Arixtra had been granted a six-month priority review. The clinical study on which this indication is based was published by Eriksson et al in the June 9, 2003 issue of the Archives of Internal Medicine - 2003;163:1337-1342. Arixtra is the only anti-thrombotic agent currently indicated in the United States for the extended prophylaxis of deep venous thrombosis in patients undergoing hip fracture surgery. This new indication is based upon the findings of a study (Penthifra-Plus) which demonstrates that in patients undergoing hip fracture surgery who were initially treated during the peri-operative period with Arixtra 2.5 mg SC once daily for 7 days followed by a 3-week extended prophylaxis period comparing Arixtra 2.5 mg once daily with placebo, in or out of the hospital, Arixtra was associated with a venous thromboembolism events (VTE) rate of 1.4% compared to a VTE rate of 35.0% for placebo for a relative risk reduction of 95.9% (95% CI=[-99.7; -87.2], p<0.0001). The rate of symptomatic VTE was 0.3% for Arixtra vs. 2.7% for placebo (p=0.021). After an usual duration of administration of 5 to 9 days, in patients undergoing hip fracture surgery an extended prophylaxis course of up to 24 additional days is recommended. As with other antithrombotics, the most common side effect during Arixtra administration is bleeding. Arixtra is contraindicated in patients with severely impaired kidney function or in patients who weigh less than 50 kg (110 pounds), because they may have an increased risk for major bleeding. Patients greater than 75 years of age also may be more likely to experience major bleeding complications. As with other antithrombotics, labeling for Arixtra includes a Boxed Warning regarding possible spinal/epidural haematomas when spinal anaesthesia or spinal puncture is used. Arixtra was launched in the United States on February 8, 2002, and in Europe as from March 27, 2002. The file for this new indication in Europe for Arixtra was submitted to the EMEA in December 2002 and is currently under review. Unlike heparins, which are from animal origin, Arixtra is a synthetic compound and the first in a new class of antithrombotic agents that selectively inhibit factor Xa. It was discovered and is being co-developed by Sanofi-Synthelabo and Organon. With this synthetic drug, Sanofi-Synthelabo and Organon intends to establish Arixtra as a reference treatment in the antithrombotic field. Further clinical investigations are being carried out to extend the use of Arixtra for the treatment of venous thrombosis and pulmonary embolism, VTE prevention in medical and surgical high risk situations and for the treatment of patients with acute coronary syndrome. SOURCE: Sanofi-Synthelabo

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