France is the first country in the world to clear the new drug, called Exanta (ximelegatran), and will act as the reference member state for the European Union-wide approval under the Mutual Recognition process.
Exanta is derived from cobra venom and promises to deliver safer and more predictable coagulation inhibition compared to warfarin. It can be given as a fixed oral dose, without the need for titration or regular anticoagulant monitoring, and also has superior food- and drug-interaction profiles.
Meanwhile, AstraZeneca has also filed for approval in the European Union and US to extend Exanta's indications to include the prevention of stroke in patients who suffer episodes of atrial fibrillation, as well as for the long-term prevention of complications in patients who have already suffered a first VTE.
Like many new cardiovascular medications for these life-threatening conditions, Exanta is expected to be something of a slow burner, gradually increasing its sales as clinicians become more proficient and comfortable with its use, particularly as its has been associated with liver enzyme elevations that might require monitoring.
Nevertheless, a recent forecast from Decision Resources predicted that Exanta would achieve sales of $2.3 billion (€1.8bn) by 2012.