GlaxoSmithKline given EC approval for new Arixtra indication

GlaxoSmithKline has been granted permission to market its anti-clotting agent Arixtra for a new specification in Europe.

The European Commission (EC) has approved the company's application to amend the drug's marketing authorisation to encompass adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs, who do not suffer from associated deep-vein thrombosis.

This applies to the drug's 1.5mg and 2.5mg formulations and comes in addition to the product's previously approved indication as a treatment against venous thromboembolic events.

GlaxoSmithKline states that the EC's decision makes Arixtra the first anti-clotting agent to be approved for this purpose.

Other specifications of the drug include treatment of unstable angina and myocardial infarctions in its 2.5mg form, while the 5mg, 7.5mg and 10mg offerings can also be used to treat acute deep-vein thrombosis and pulmonary embolisms.

Last month, GlaxoSmithKline was granted permission to amend the European label of its cervical cancer vaccine Cervarix to include a wider range of specified conditions.