GSK's Arixtra gets FDA approvable letter

UK-based drug major GlaxoSmithKline says that the US Food and Drug Administration has issued an approvable letter in relation to its anticoagulent Arixtra (fondaparinux sodium). The product was originally developed by French drugmaker Sanofi-Aventis, but was purchased by GSK in 2004 as part of a 453.0 million-euro ($546.8 million) deal (Marketletters passim).

GSK explained that it is seeking clearance for the drug, which is already approved for the treatment of deep vein thrombosis, as a therapy for patients with unstable angina and myocardial infarction. The firm said that the FDA's approvable letter follows the agency's priority review of the product, which was initiated late last year (Marketletter October 16, 2006), and added that the submission included data from the pivotal OASIS 5 and 6 trials.

The company said that it would continue to work with the FDA in order to provide additional information to support its submission, and added that, assuming it is approved for the new indication, it would make the drug available for the treatment of a broad range of patients with acute coronary syndromes, including both non-ST segment and ST segment elevated myocardial infarction.