FDA Grants Priority Review For ARIXTRA (Fondaparinux Sodium) In The Treatment Of Acute Syndromes

Pivotal Trials of the Anticoagulant ARIXTRA Submitted to FDA by GlaxoSmithKline

Philadelphia, PA - GlaxoSmithKline plc announced that the supplemental new drug application for its anticoagulant product ARIXTRA (fondaparinux sodium) Injection has been accepted for priority review by the United States Food and Drug Administration. This application was based on positive results from two pivotal, Phase III trials (OASIS 5 and 6) that evaluated ARIXTRA in the treatment of a broad spectrum of patients with acute coronary syndromes (ACS). The sNDA was submitted on July 31, 2006.

The filing submission data included the OASIS 5 clinical trial results, which compared ARIXTRA to LOVENOX (enoxaparin)* in patients with UA/NSTEMI**1, and OASIS 6, which compared ARIXTRA to standard therapies (unfractionated heparin or placebo) in STEMI*** patients.

"GSK is very encouraged by the FDA's decision, based on these two ground-breaking clinical trials with ARIXTRA in ACS," said Dr. Lawson Macartney, Senior Vice-President, Cardiovascular and Metabolic Medicine Development Centre, GlaxoSmithKline. "This application supports our commitment to patients, physicians and the cardiovascular community. We look forward to building on our existing indications with ARIXTRA."

SOURCE: GlaxoSmithKline