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Opinions on drugs - Posted on Jul 04 2012

Reason for request

Inclusion on the list of medicines approved for hospital use in the new indication: “Fibrinolytic treatment of acute ischaemic stroke within 4.5 hours after onset of symptoms”, as opposed to within 3 hours in the previous indication.


Clinical Benefit


The actual benefit of ACTILYSE is substantial in the new indication.

Clinical Added Value


Given the absence of long-term efficacy data, the low level of quantity of effect of alteplase versus placebo and the risk of intracranial haemorrhage, ACTILYSE provides a moderate improvement in actual benefit (IAB III) in the treatment of ischaemic stroke in the extension of the treatment window (0 - 4.5 h instead of 0 - 3 h) following the onset of stroke symptoms.

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