GSK's Arixtra gets fast tracked by US FDA

GlaxoSmithKline says that a supplemental New Drug Application for its anticoagulant Arixtra (fondaparinux sodium) injection has been accepted for priority review by the US Food and Drug Administration. The UK drug major's application was based on positive results from two pivotal, Phase III trials (OASIS 5 and 6) that evaluated the agent in the treatment of a broad spectrum of patients with acute coronary syndromes.

The submitted data included the OASIS 5 clinical trial results, which compared Arixtra to Sanofi-Aventis' Lovenox (enoxaparin) in patients with unstable angina and non-ST elevation myocardial infarction, and OASIS 6, which compared Arixtra to standard therapies (unfractionated heparin or placebo) in ST-elevation myocardial infarction patients.

The first-in-class of antithrombotic 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 blood protein that facilitates blood clotting.