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news.GlaxoSmithKline (GSK) has received an amendment of their marketing authorisation, from the European Commission (EC), for their anti-clotting agent (antithrombotic), Arixtra (fondaparinux), as a new therapeutic indication in the EU.
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Fondaparinux 1.5 and 2.5mg is indicated for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
Fondaparinux has received approval for use in the EU for the prevention of venous thromboembolic events (VTE), 2.5mg is additionally approved for the treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and for the treatment of ST segment elevation myocardial infarction (STEMI).
Additionally, 5mg, 7.5mg and 10mg are approved for initial treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE).