Arixtra cleared in EU for superficial vein thrombosis

GlaxoSmithKline has won approval from the European Commission to market its clot-dissolving drug Arixtra (fondaparinux) for superficial vein thrombosis, making it the first treatment to be cleared for the indication in the EU.

Specifically, the UK-based drugmaker got a green light from the European Commission to market Arixtra for the treatment acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs, in adults who do not have concomitant deep vein thrombosis (DVT).

The new indication for Arixtra was backed by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) back in July on the strength of the results of GSK's CALISTO trial comparing the drug with placebo in SVT patients.