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GSK's Arixtra gets EU approval to treat heart disease

London, UKTuesday, September 4, 2007, 08:00 Hrs  [IST]

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 conditionsaffect approximately 3 million people worldwide1,2 andinclude 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. Fondaparinux is indicated for the treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (<120 minutes) invasive management (PCI) is not indicated. Data from OASIS 5, one of the largest clinical trials ever conducted in patients with ACS, showed that fondaparinux is of similar efficacy to Lovenox/ Clexane (enoxaparin) in patients suffering unstable angina and non-ST elevation myocardial infarction, and was associated with a significant lower risk of bleeding at day 9 and a significant mortality benefit at day 30. The OASIS 5 clinical trial compared fondaparinux 2.5mg once daily to enoxaparin 1mg/kg twice daily in patients with UA/NSTEMI. Fondaparinux was associated with a significant 48% (p<0.001) reduction in major bleeding vs. enoxaparin (2.2% and 4.1% incidence, respectively) up to 9 days.4 The study also showed that fondaparinux significantly reduces mortality compared to enoxaparin at one month.4 Mortality rates at one month were 2.9 % in the patient group receiving fondaparinux and 3.5% in the patient group receiving enoxaparin, representing a 17% reduction (p=0.02) in favour of fondaparinux. Fondaparinux is indicated for the treatment of STEMI in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. Data from OASIS 6, one of the largest clinical trials conducted in patients with STEMI, showed that fondaparinux is more efficacious than standard therapy and that this improved efficacy was achieved with no increased risk of bleeding compared to standard therapies. OASIS 6 compared fondaparinux to standard therapies (unfractionated heparin or placebo) in STEMI patients. The overall results of the OASIS 6 study demonstrated greater efficacy of fondaparinux compared to standard therapy in reducing risk of death or recurrent heart attack (risk reduction of 14% at day 30, p=0.008).5 Fondaparinux is the first in a class of antithrombotics that selectively inhibits Factor Xa, a central protein in the coagulation process. In the treatment of thrombosis, Factor Xa plays a central role in the generation of thrombin, a protein in blood that facilitates blood clotting.

 
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