Value through Innovation27 August 2014
11 October 2012

NICE recommends treatment with alteplase is started as early as possible, within 4.5 hours of onset of ischaemic stroke symptoms

- Until today Actilyse® (alteplase, rt-PA) is the only approved treatment option for patients with acute ischaemic stroke

- Early thrombolysis is and stays important and can increase the benefit for acute ischaemic stroke patients

Ingelheim, Germany, 11th October 2012 - NICE has issued final guidance on the use of alteplase (Actilyse) for the treatment of acute ischaemic stroke[1], 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.

About Actilyse®
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.

For more information please visit www.strokeforum.com

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

References

1Alteplase for treating acute ischaemic stroke. NICE Technology Appraisal 264. September 2012.
www.nice.org.uk/ta264

2Rudd AG et al on behalf of the Intercollegiate Working Party for Stroke. Stroke thrombolysis in England, Wales and Northern Ireland: how much do we do and how much do we need? Journal of Neurology, Neurosurgery and Psychiatry 2011; 82: 14-19

3Bembenek J et al. How many patients might receive thrombolytic therapy in the light of the ECASS-3 and IST-3 data? International Journal of Stroke. 2010; 5: 430

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