Exanta promise for AstraZeneca
pharmafile | October 27, 2003 | News story | |
AstraZeneca's new anticoagulant Exanta has shown to be more effective than warfarin in preventing stroke in patients suffering from arrhythmia.
Exanta (ximelagatran) is also tipped to be a blockbuster with estimated peak sales of between $2 billion and $3 billion.
Results from the SPORTIF (Stroke Prevention by Oral Thrombin Inhibitor in Atrial Fibrillation) III trial of 3,400 people showed patients that suffered from atrial fibrillation a type of arrhythmia that has been linked to stroke and congestive heart failure taking Exanta were less likely to suffer a stroke than those taking warfarin.
Patients taking Exanta also showed a lower level of bleeding than the warfarin group.
Exanta is the first in a new class of anticoagulants the oral direct thrombin inhibitors (DTI) and the first oral anticoagulant since warfarin was introduced over 50 years ago. US and European marketing submissions are on track for the fourth quarter of the year.
It has proven to be much simpler treatment than warfarin. Patients taking the older drug need constant monitoring and dose adjustment, and must go on a special diet to avoid possible interactions.
Some concern has, however, been raised over Exanta's potential to raise liver enzymes a condition that can lead to liver damage.
This side-effect was seen in 6.5% of the patients in the SPORTIF trial, though AstraZeneca said this was a transient effect that passed after six months whether treatment was continued or not.
Exanta is also under European review for the treatment of venous thromboembolism (VTE) in post-operative surgery, competing against Aventis' market-leading Lovenox/Clexane. A US filing is expected in the fourth quarter, as is European submission for the treatment of VTE.
The phase III results come as relief to AstraZeneca, whose two other major new products, statin Crestor and lung cancer drug Iressa, are still dogged by delays and safety concerns.
