The European Medicines Agency‘s (EMEA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on extending the use of GlaxoSmithKline’s Arixtra (fondaparinux sodium) for prevention of venous thromboembolic events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.

The opinion was based on the results of the PEntasaccharide GenerAl SUrgery Study (PEGASUS). This study demonstrated that Arixtra is at least as effective as dalteparin in reducing the risk of total VTE. 4.6 per cent of patients on Arixtra experienced a VTE versus 6.1 per cent of patients on dalteparin. In the large subgroup of patients undergoing cancer surgery, representing 69 per cent of the patient population, 4.7 per cent of Arixtra patients experienced a VTE versus 7.7 per cent in the dalteparin group.

“The CHMP’s positive opinion on use of Arixtra for VTE prophylaxis in abdominal surgery is a welcome, positive sign that patients who are judged to be at high risk of thromboembolic complications may soon have an effective new therapy option available,” said Andrew Witty, president of GlaxoSmithKline Pharmaceuticals Europe.

PEGASUS was a double-blind study performed in 131 centres in 22 countries. A total of 2,927 patients were randomized to receive Arixtra 2.5 mg once daily or dalteparin 5000 IU once daily (2500 IU administered as a pre-operative and first post-operative dose) for 7+2 days.