Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News GSK receives new EMEA approval of Arixtra

GSK receives new EMEA approval of Arixtra

3rd September 2007

GlaxoSmithKline (GSK) has announced that it has received authorisation for a new indication of Arixtra (fondaparinux sodium), the compound being approved as a treatment for specific acute coronary syndromes by the European Medicines Agency (EMEA).

Authorisation from the EMEA is based on the positive results of pivotal phase III clinical trials assessing the efficacy of fondaparinux when compared to enoaparin, unfractioned heparin or placebo.

This approval occurs at the same time as the publication of guidelines from the European Society of Cardiology exclusively giving fondaparinux the highest recommendation as a treatment for unstable angina and non-ST-elevation myocardial infarction patients while a decision between conservative and early invasive treatment is pending.

Andrew Zambanini, director of the cardiovascular and metabolic medicine development centre at GSK, said: “The mortality benefit with fondaparinux compared to enoxaparin and the European authorisation of fondaparinux may allow physicians to consider a new treatment option for appropriate [acute coronary syndrome] patients.”

He added that the firm is dedicated to supporting the development of treatments of patients across the world suffering with cardiac conditions.

In February 2006, GlaxoSmithKline reported the results of a medical indications study which found that administration with Arixtra reduced the risk of contracting venous thromboembolism by 46.7 per cent.

We currently have 9 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.