Actilyse gets stroke indication in EU

Boehringer Ingelheim's tissue plasminogen activator Actilyse(alteplase) has become the first drug to be approved in the European Union as a treatment for acute ischemic stroke. The drug has been cleared for use in stroke patients in the USA, where it is sold by Genentech as Activase, for nearly seven years (Marketletters passim).

Actilyse has been EU-approved for the treatment of selected patients with acute ischemic stroke, which has been confirmed using computed tomography or magnetic resonance imaging scanning, who present for treatment within three hours of the onset of symptoms. The requirement for scanning is in order to avoid use of the drug in patients with a hemorrhagic stroke, in which treatment with a thrombolytic would be contra-indicated.

The use of thrombolysis in stroke has had a checkered past, with much of the initial enthusiasm surrounding the approval of Activase in the USA tempered by subsequent studies which suggested that another thrombolytic, streptokinase, might have a negative impact on survival. Meantime, other trials attempting to extend the treatment window beyond three hours have not been successful, while a study published in 2000 suggested that Activase was associated with an in-hospital death rate of 15.7% among ischemic stroke patients, more than three times the mortality seen among those who did not receive the drug, with all those on Activase who died suffering cerebral hemorrhage (Marketletters passim).