Arixtra tops LMWH in meta-analysis

Sanofi-Synthelabo and Organon's selective Factor Xa inhibitor, thepentasaccharide drug Arixtra (fondaparinux sodium), has been shown to provide superior efficacy to Aventis' low-molecular weight heparin Clexane/Lovenox (enoxaparin) in the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing major orthopedic surgery, according to a meta-analysis of four Phase III trials presented at the International Society on Thrombosis and Hemostasis meeting in Paris, France.

The analysis revealed that Arixtra was associated with an overall risk reduction of 50% compared to enoxaparin, and there were no significant differences between the drugs with regard to death and clinically-important bleeding criteria. One interesting finding was that Arixtra's benefits appeared to be independent of the timing of its post-operative administration, although a delay of at least six hours after surgery was associated with a more favorable bleeding profile.

Arixtra has been submitted for approval in the USA and Europe, and has been granted fast-track review by the US Food and Drug Administration (Marketletters passim). Analysts have predicted that turnover of the drug could reach more than $300 million by 2005.