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European Union Expands Fondaparinux Indication To Include Extended Use in Prophylactic Treatment

Paris, November 19, 2003 -- Sanofi-Synthélabo and Organon announced today that Arixtra® (fondaparinux sodium) has received marketing authorization from the European Commission for an extended duration of prophylactic treatment of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture surgery.

Arixtra® is indicated in the European Union for the “Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee or hip replacement surgery”.

The new labelling provides that for all these indications, the treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery. Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery. In these patients the use of prolonged prophylaxis with Arixtra® should be considered for up to an additional 24 days.

This extended treatment duration will allow clinicians to give what has been demonstrated to be very effective prophylaxis for the appropriate amount of time in hip fracture patients who have the highest risk of suffering VTE. This is a fact already recognised in recent guidelines issued by clinical expert societies in a number of European countries.

Arixtra® is the only anti-thrombotic agent currently indicated in all the European Union countries and in the United States for the extended prophylaxis of deep venous thrombosis in patients undergoing hip fracture surgery.

The clinical study on which this indication is based, Penthifra-Plus, was published by Eriksson et al in the June 9, 2003 issue of the Archives of Internal Medicine – 2003;163: 1337-1342. This international randomised double-blind, placebo-controlled study demonstrates that patients undergoing hip fracture surgery treated with four weeks of Arixtra 2.5 mg SC once daily, in or out of the hospital, had a VTE rate of only 1.4%. The rate of symptomatic VTE was also reduced to 0.3% with Arixtra® extended prophylaxis, the lowest level ever reached in this high risk patient group, with no pulmonary embolisms the most feared outcome of VTE. There were no differences between Arixtra® and the placebo in the incidence of clinically relevant bleeding.

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.

Arixtra® was launched in the United States on February 8, 2002, and in Europe as from March 27, 2002. The file for this new treatment duration in Europe for Arixtra® was submitted to the EMEA in December 2002, and the Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion in July 2003. Arixtra® has received marketing approval for extended prophylaxis in the US in June 2003, after a six-month priority review.

As with other antithrombotics, the most common side effect during Arixtra® administration is bleeding. Arixtra® is contraindicated in patients with severely impaired kidney function and 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 or epidural haematoma when epidural/spinal anaesthesia or spinal puncture is used.

Source: Sanofi-Synthélabo and Organon

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