Posted on 05/08/2010 in Pharmacy Supplier News GlaxoSmithKline has been given a recommendation for regulatory clearance to launch Europe's first superficial vein thrombosis (SVT) treatment Arixtra.
The European Medicines Agency's Committee for Medicinal Products for Human Use has granted a positive opinion to the fondaparinux-based treatment to be approved for sufferers of acute SVT of the lower limbs without concomitant deep-vein thrombosis.
GlaxoSmithKline was granted the approval based on positive data from the Calisto clinical trial, which illustrated the efficacy of the treatment compared to placebo.
Dr Tony Hoos, senior vice-president of European medical affairs at GlaxoSmithKline, said: "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."
The drug has already been approved in the EU as a therapy against venous thromboembolic events and other conditions.
According to the company's most recent fiscal report, sales of GlaxoSmithKline consumer health products grew by three per cent year-on-year in the second quarter of 2010. Other news stories from 05/08/2010
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