GlaxoSmithKline announced that the European Medicines Agency (EMEA) has authorised a new indication for its once-daily anticoagulant ARIXTRA? 2.5 mg (fondaparinux sodium) for the treatment of specific acute coronary syndromes (ACS).
ACS conditions affect approximately 3 million people worldwide and include chest pain (unstable angina [UA]) and two specific types of heart attacks (NSTEMI and STEMI).
“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 ACS patients,” said Andrew Zambanini, MD, Director, Cardiovascular and Metabolic Medicine Development Centre, GSK. “GSK is committed to continuing to support therapies for cardiac patients around the world.”
This authorisation coincides with newly published European Society of Cardiology guidelines that have given only fondaparinux the highest (grade 1A) recommendation for the anticoagulant treatment of UA/NSTEMI patients, as long as a decision between early invasive (<72 hours) or conservative strategy is pending.Authorisation of the ACS indication was based on positive results from two pivotal Phase III trials including more than 32,000 patients that evaluated fondaparinux versus enoxaparin (OASIS 5) or standard therapies of unfractionated heparin or placebo (OASIS 6) for the treatment of selected patients with ACS.The company?s application for the ACS indication was submitted to European regulators on 31 July, 2006. On 21 June, 2007, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for fondaparinux in patients with ACS.