FDA Reviewing ACS Drug

 

October 5, 2006

FDA has accepted ARIXTRA (fondaparinux sodium) Injection for priority review — the anticoagulant supplemental drug developed by GlaxoSmithKline achieved 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 filing submission data included the OASIS 5 clinical trial results, which compared ARIXTRA to LOVENOX (enoxaparin) in patients with UA/NSTEMI, and OASIS 6, which compared ARIXTRA to standard therapies (unfractionated heparin or placebo) in STEMI patients(2).

ARIXTRA is not currently approved for patients with ACS in any country in the world.

For more information as well as warnings and contraindications, visit www.gsk.com.