Regulators have approved the wider use of UK drugmaker GlaxoSmithKline’s clot-busting medicine Arixtra (fondaparinux) throughout the European Union.
The European Commission has given the all clear for GSK to market its drug for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
The move follows a positive decision by the Committee for Medicinal Products for Human Use earlier this year, and comes the back of data from the CALISTO study (Comparison of Arixtra in lower LImb Superficial vein Thrombosis with placebO), which, according to GSK, is the first study in SVT to show a clinical effect with an anticoagulant treatment versus placebo.
This means Arixtra is now the only anti-clotting agent to have this indication, which adds to its other approved uses in Europe for preventing venous thromboembolic events and treating unstable angina or non-ST segment elevation myocardial infarction, ST segment elevation MI and initial treatment of acute deep vein thrombosis and pulmonary embolism.
“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,” Tony Hoos, SVP, European Medical Affairs, at GSK, previously noted.
Arixtra is the first in a class of antithrombotics that selectively inhibit Factor Xa, which plays a key role in production of the blood-clotting agent thrombin, and the drug pulled in sales of £149 million for the first six months of this year.