GSK RECEIVES APPROVABLE LETTER FOR NEW ARIXTRA INDICATIONS

GlaxoSmithKline (GSK) announced that the FDA has issued an approvable letter for the company's once-daily anticoagulant, Arixtra (fondaparinux sodium), for treating patients with acute coronary syndromes (ACS). Specifically, GSK hopes to receive approval of Arixtra for treating patients with unstable angina or non-ST segment elevation myocardial infarction and ST-segment elevation myocardial infarction.

In October 2006 the FDA granted priority review to GSK's supplemental new drug application for Arixtra for treating patients with ACS. The company had submitted the application in July.

The submission was based on results from the OASIS 5 trial, which compared Arixtra with Lovenox (enoxaparin) in patients with unstable angina and non-ST-elevation myocardial infarction (heart attack), and the OASIS 6 trial, which compared Arixtra with standard therapies (unfractionated heparin or placebo) in ST-elevation myocardial infarction (severe heart attack) patients. Results of the clinical studies have been published in the New England Journal of Medicine and The Journal of the American Medical Association.

GSK said it will continue to work with the FDA to provide the additional information requested to complete the assessment of Arixtra for these indications. Arixtra is currently approved for the prevention of venous thromboembolism in patients undergoing surgery for hip fracture, knee replacement, hip replacement and in abdominal surgery patients who are at risk for thromboembolic complications. Additionally, the drug is indicated for use in conjunction with warfarin sodium for treating acute deep-vein thrombosis and acute pulmonary embolism.