EU green light for new Arixtra indication

by | 4th Feb 2005 | News

GlaxoSmithKline was celebrating this morning after winning European approval to use its anti-thrombotic, Arixtra (fondaparinux), in the prevention of venous thromboembolic events in patients who judged to be at high risk of thromboembolic complications. The firm says that the new use extends to patients who are immobilised due to acute illness such as cardiac insufficiency, acute respiratory disorders, acute infectious disease, and/or acute inflammatory disease.

GlaxoSmithKline was celebrating this morning after winning European approval to use its anti-thrombotic, Arixtra (fondaparinux), in the prevention of venous thromboembolic events in patients who judged to be at high risk of thromboembolic complications. The firm says that the new use extends to patients who are immobilised due to acute illness such as cardiac insufficiency, acute respiratory disorders, acute infectious disease, and/or acute inflammatory disease.

Arixtra is already approved in Europe for the prevention of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing surgery for hip fracture, knee replacement, and hip replacement. “The [EC’s] decision to extend use of Arixtra to treat the acutely ill who are at high risk of thromboembolic complications offers a vital new therapeutic option for these patients,” said Andrew Witty, president of GSK pharmaceuticals Europe.

GSK bought Arixtra, together with the thrombolytic, Fraxiparine (nadroparine), and a manufacturing plant in France from Sanofi-Synthelabo in September last year – the sale was one of the approval conditions of the French firm’s takeover of Franco-German rival, Aventis [[13/04/04a]], [[02/09/04a]].

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