NICE has issued final guidance on the use of alteplase (Actilyse) for the treatment of acute ischaemic stroke, which recommends initiation of treatment within 4.5 hours of onset of ischaemic stroke symptoms. This will give more patients access to thrombolytic therapy, though it remains crucial that doctors treat stroke patients as early as possible.
This recommendation comes as the result of a review of existing NICE guidance for Actilyse in stroke, prompted by an extension to the marketing authorisation which allows the initiation of Actilyse from 3 to 4.5 hours from the onset of ischaemic stroke symptoms.
The NICE Appraisal Committee concluded that Actilyse administered between 0 and 4.5 hours after onset of stroke symptoms was a cost-effective treatment for acute ischaemic stroke as it decreases the probability of disability, death or dependence.
The recommendation made by NICE that treatment should be started as early as possible within 4.5 hours of onset of stroke symptoms is vitally important. An extended treatment window from 3 to 4.5 hours allows a greater number of eligible patients to be safely and effectively thrombolysed, but it is crucial to keep in mind that the Actilyse licence extension provides more time for patients, not for clinicians; it remains necessary that patients eligible for thrombolysis are treated without delay to maximise effectiveness.
Stroke is a neurological emergency that can affect a specific area, or sometimes all of the brain. It can be caused by a burst blood vessel (haemorrhagic stroke) or occur when a vessel is obstructed by a blood clot (ischaemic stroke). Actilyse® (active ingredient: alteplase), is now in the majority of EU approved for use within 4.5 hours from the onset of symptoms in ischaemic stroke. It is a recombinant tissue plasminogen activator (rt-PA), a genetically engineered version of naturally occurring tissue plasminogen activator, which has the biological function of removing small clots that routinely form in the bloodstream.
Actilyse® is the only drug indicated for thrombolytic treatment of patients with acute ischaemic stroke and is recommended by international treatment guidelines. Actilyse® was first approved in 1987 in major countries across the globe in the indication acute myocardial infarction, followed by subsequent approvals in the indications (acute) pulmonary embolism and acute ischaemic stroke (registered indications can vary across the globe). Actilyse® is registered in over 85 countries across the world and marketed outside North America and Japan by Boehringer Ingelheim.
Alteplase is marketed under the brand name Activase® in the U.S.A. by Genentech, Inc. and in Canada by Roche Canada, where it has been used extensively for the treatment of acute ischaemic stroke since 1996 and 1999, respectively.
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