GlaxoSmithKline says that the Euroepan Commission has given the thumbs up to a new use for the company’s anti-thrombotic, Arixtra (fondaparinux) – in the prevention of venous thromboembolic events in patients undergoing abdominal surgery.

Approval, which comes less than two months after the continent’s advisory panel gave its backing to the new indication [[27/05/05f]], was based on the results of the 2,927-patient Pegasus trial, which showed that Arixtra was at least as effective as the anti-thrombolytic drug, dalteparin, in reducing the risk of total VTE. Some 4.6% of Arixtra patients experienced a VTE during the trial, versus 6.1% of those receiving dalteparin. Patients with cancer are amongst those judged to be at high risk of thromboembolic complications during abdominal surgery and, in a subgroup of patients undergoing cancer surgery – representing 69% of the study’s patient population – 4.7% of Arixtra patients experienced a VTE versus 7.7% in the dalteparin group.

GSK bought the rights to Arixtra, which was first approved in Europe for the prevention of VTE in patients undergoing major orthopaedic surgery of the lower limbs [[28/03/02f]], from Sanofi-Synthelabo last year together with the thrombolytic, Fraxiparine (nadroparine), and a manufacturing plant in France. The sale was one of the approval conditions of the French firm’s takeover of Franco-German rival, Aventis [[02/09/04a]].