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news.The European Medicines Agency has authorized a new indication for GlaxoSmithKline's once-daily anticoagulant Arixtra 2.5mg for the treatment of specific acute coronary syndromes.
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Authorization of the acute coronary syndromes (ACS) indication was based on positive results from two pivotal Phase III trials including more than 32,000 patients that compared Arixtra (fondaparinux) to Sanofi-Aventis's Lovenox (enoxaparin) or standard therapies of unfractionated heparin or placebo for the treatment of selected patients with ACS.
“The mortality benefit with fondaparinux compared to enoxaparin and the European authorization of fondaparinux may allow physicians to consider a new treatment option for appropriate ACS patients,” said Andrew Zambanini, director of Cardiovascular and Metabolic Medicine Development Centre, GSK.
“GSK is committed to continuing to support therapies for cardiac patients around the world.”