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GSK obtains CHMP positive opinion for new indication for Arixtra.

M2 PHARMA-July 23, 2010-GSK obtains CHMP positive opinion for new indication for Arixtra(C)2010 M2 COMMUNICATIONS

23 July 2010 - UK GlaxoSmithKline (LON: GSK) said today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arixtra (fondaparinux), an anti-clotting drug (antithrombotic) for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis.

The decision was granted via the centralised filing procedure with Sweden as the rapporteur and France the co-rapporteur. The decision was supported by the results of the CALISTO study (Comparison of Arixtra in lower LImb Superficial vein Thrombosis with placebO), the first study in SVT to show a clinical effect with an anticoagulant treatment versus placebo, the company said.

Fondaparinux is currently approved for use in the EU for the prevention of venous thromboembolic events (VTE), initial treatment of acute deep vein thrombosis (DVT), pulmonary embolism (PE) treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and for the treatment of ST segment elevation myocardial infarction (STEMI).

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Publication:M2 Pharma
Date:Jul 23, 2010
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