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news.The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), has issued a positive opinion for Arixtra (fondaparinux) to GlaxoSmithKline (GSK).
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GSK said that Arixtra is an anti-clotting drug (antithrombotic) which is indicated for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis.
CHMP stated that its decision was granted via the centralised filing procedure with Sweden as the rapporteur and France the co-rapporteur.
Further, the agency said that its the positive opinion was based on CALISTO study (Comparison of Arixtra in lower LImb Superficial vein Thrombosis with placebO) results.
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).
Tony Hoos, European medical affairs of GSK, said: “We are very glad that healthcare providers now have fondaparinux as a licensed treatment option for patients with superficial vein thrombosis. We expect that fondaparinux will be an important option for the treatment of SVT”