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First EU approval for Actilyse


Boehringer Ingelheim have announced the first approval for Actilyse (alteplase) 2mg within the European Union, which was communicated by the reference Member State Germany after successful completion of a mutual recognition procedure. The new indication is for the thrombolytic treatment of occluded central venous access devices (CVAD), including those used for haemodialysis.

This regulatory milestone will result in subsequent approvals of the new indication in the relevant countries of the European Union throughout 2008 onwards.

Actilyse is already registered in more than 85 countries across the world for the indications acute myocardial infarction, acute massive pulmonary embolism, and acute ischaemic stroke.

A dose of up to 2mg of Actilyse administered up to two times into the occluded central venous access device, can restore function of catheters, including those used for haemodialysis, which become dysfunctional due to thrombotic occlusion. Actilyse 2mg works by activating plasminogen, which dissolves fibrin (a substance that causes blood to clot), breaking down the thrombus and restoring function to the CVAD.

Catheter dysfunction may be caused by a variety of conditions, such as catheter malposition, mechanical failure, constriction by a suture, lipid deposits or drug precipitates within the catheter lumen and importantly by thrombus formation.

“Until now, there have been limited treatment options available in Europe to healthcare professionals to restore catheter function following thrombotic occlusion,” said Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine worldwide.

“In many cases, the only option has been to remove and replace the catheter. Therefore, the approval of this new indication for alteplase is welcome news for physicians and for the many patients who rely on central venous access devices for their medical care.”

Boehringer Ingelheim

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