GSK receives CHMP positive opinion for a new indication for Arixtra

GlaxoSmithKline (GSK)GlaxoSmithKline (GSK) announced that the European Medicines Agency's 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.

"We are very glad that healthcare providers now have fondaparinux as a licensed treatment option for patients with superficial vein thrombosis. SVT is a condition that can lead to serious and even life threatening complications. We expect that fondaparinux will be an important option for the treatment of SVT" said Dr. Tony Hoos, SVP, European Medical Affairs, GSK.

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.(1)

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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1. D├ęcousus H, Prandoni P, Leizorovicz A, Fondaparinux 2.5 mg for the Treatment of Symptomatic, Isolated Superficial Vein Thrombosis (SVT): Preliminary Data from the Randomized Placebo-Controlled CALISTO Trial (on Behalf of the CALISTO Investigators) American Society of Hematology Annual Meeting 2009 Abstracts 114: Abstract 171.