GlaxoSmithKline plc has been granted a licence for use of Arixtra (fondaparinux sodium) in the prevention of venous thromboembolic events (VTE) in medical patients who are judged to be at high risk of thromboembolic complications by the European Commission.
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 an anti-thrombotic agent already approved for use in the European Union (EU) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients undergoing surgery for hip fracture (including extended prophylaxis), knee replacement, and hip replacement. Additionally, Arixtra Injection is indicated for the treatment of acute DVT and the treatment of acute PE, except in haemodynamically unstable patients who require thrombolysis or pulmonary embolectomy, a GSK release said.
"The European Commission'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 GlaxoSmithKline Pharmaceuticals Europe.
Arixtra is the first selective inhibitor of Factor Xa, a central protein in the coagulation process. It was first authorised for use in the EU in March 2002 for the prevention of VTE in patients undergoing major orthopaedic surgery of the lower limbs. Arixtra is currently marketed in 30 countries, including major European markets and the United States.
In Europe, GSK became the Marketing Authorisation Holder (MAH) for Arixtra (and Quixidar) on 31 January 2005. GSK finalised the acquisition of the injectable anti-thrombotic agents Arixtra, Fraxiparine, Fraxodi and related assets from Sanofi-Aventis in September 2004.
The Commission decision follows a positive opinion on this new indication for Arixtra by the European Agency for the Evaluation of Medicinal Products' (EMEA) Committee for Medicinal Products for Human Use (CHMP) on 15 December 2004. Arixtra is not approved for this use in the United States.