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news.GlaxoSmithKline has received a positive recommendation from a European agency to extend the use of thrombosis drug Arixtra for prevention of venous thromboembolic events in patients undergoing abdominal cancer surgery.
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The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion to extend the use of Arixtra (fondaparinux sodium) to patients judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.
The opinion was based on the results of a study which successfully demonstrated that Arixtra is at least as effective as dalteparin in reducing the risk of total venous thromboembolic events (VTE). The study also analyzed data from a large subgroup of patients undergoing cancer surgery, representing 69% of the patient population. Within this group, fewer patients receiving Arixtra experienced a VTE than those treated with dalteparin.
“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.
The European Commission usually endorses the recommendations of the CHMP.