Arixtra approved for new blood clot indication
pharmafile | July 20, 2005 | News story | Sales and Marketing |Â Â Arixtra, GlaxoSmithKlineÂ
GlaxoSmithKline’s Arixtra has gained approval for use in preventing blood clots in high-risk patients undergoing abdominal surgery.
The drug is already licensed for the same purpose in patients undergoing hip or knee surgery as well as acutely ill patients, and the new indication will help GSK increase sales of the product, which it acquired from Sanofi-Synthelabo in April 2004.
The European Commission has approved the new indication of preventing venous thromboembolic events (VTE) in high-risk patients, such as those undergoing abdominal cancer surgery.
The approval was based on data from a trial which showed Arixtra (fondaparinux) was as least as good as Pfizer’s Fragmin (dalteparin) at reducing the risk of total VTE, with data showing Arixtra slightly better in preventing a clot.
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