ESO recommends extended time window for Actilyse®
For medical media, outside the US only
Ingelheim/Germany, 28 January 2009 - Based on key results from the European Cooperative Acute Stroke Study (ECASS 3), the European Stroke Organisation (ESO) now recommends that Actilyse® (alteplase) be given within 4.5 hours of onset of ischaemic stroke, although treatment beyond 3 hrs from the the onset of stroke currently is not included in the European labelling.1 ECASS 3, a randomised, double-blind, placebo-controlled trial, showed for the first time that thrombolysis with Actilyse® can increase the likelihood of achieving good outcome with only minimal or no disability after an acute ischaemic stroke when administered in an extended time-window from 3 to 4.5 hours after symptom onset.2 This news comes shortly after The Lancet selected ECASS 3 as one of the top three papers of 2008, and Lancet editors singled out the study as their choice for paper of the year.3
Writing in the 24 January 2009 issue of The Lancet, Executive Editor William Summerskill said that ECASS 3 and the other papers of the year “embody the can-do spirit of visionary research. They extend the horizon of our understanding and add to our tools for treating important common health problems that were once believed overwhelming.”
The World Health Organization estimates that 5.7 million people in the world die each year from stroke.4 Among survivors, 40% experience moderate to severe disability and 10% require institutional care.5 For patients with an acute ischaemic stroke the only treatment currently available is Actilyse®, which has to be administered within 3 hours of symptom onset according to its currently approved label. The ECASS 3 trial was set up to investigate whether Actilyse® can show a net-benefit of treatment in the 3 to 4.5 hour time window.. ECASS 3 included 821 patients in 15 European countries who were recruited by a team of investigators led by Professor Werner Hacke of the University of Heidelberg. Results were published in the New England Journal of Medicine in September 2008.2
Dr. Manfred Haehl, Corporate Senior Vice President Medicine, Boehringer Ingelheim said: “We are proud of the success of ECASS 3 and would like to thank our lead investigator, all the investigators throughout Europe, the trial team and most notably patients and their relatives for their participation in this landmark study in acute ischaemic stroke. Boehringer Ingelheim is committed to seeking an update to the Actilyse® label and will present the new clinical evidence generated by ECASS 3 to regulatory authorities as soon as possible.”
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This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
Notes to Editor
About ECASS 3
ECASS 3 was a randomised, double-blind, multicentre, placebo-controlled trial of Actilyse® in acute ischaemic stroke where thrombolysis is initiated between 3 and 4.5 hours after stroke onset. The study, sponsored by Boehringer Ingelheim, was requested by European authorities to support the licencing of Actilyse®. ECASS 3 started in July 2003 and was completed in February 2008. The patients included in the study were in line with the Actilyse® indication in the European Summary of Product Characteristics6 with the exception of the time window.
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 approved for use within 3 hrs from the onset of 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 acute ischaemic stroke within three hours of symptom onset, and is recommended by international treatment guidelines.7,8 In line with the current Actilyse® label, patients need to receive the medication within three hours of the onset of their stroke symptoms.5 Alteplase was first approved in 1987 in major countries across the globe in the indication acute myocardial infarction, followed by subsequent approvals in the indications 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.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
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1 European Stroke Organisation. ESO GC Statement on revised guidelines for intravenous thrombolysis. January 2009. http://www.eso-stroke.org/pdf/ESO_Guideline_Update_Jan_2009.pdf Accessed 28 January 2009.
2 Hacke W, et al for the ECASS investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008; 359: 1317–1329
3 Summerskill W. Paper of the year 2008: results. Lancet 2009; 373: 283–284
4 Cardiovascular diseases. Fact sheet N°317. February 2007. WHO. https://www.who.int/mediacentre/factsheets/fs317/en/
5 National Institute of Neurological Disorders and Stroke. Stroke Rehabilitation Information. http://www.ninds.nih.gov/disorders/stroke/stroke_rehabilitation.htm Accessed 27 January 2009
6 Actilyse® Summary of Product Characteristics 2007. Available at: http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=308
7 European Stroke Organisation (ESO) Executive Committee; ESO Writing Committee. Guidelines for management of ischaemic stroke and transient ischaemic attack 2008. Cerebrovasc Dis 2008; 25: 457–507
8 Strokeupdate.org. Stockholm: Thrombolysis for acute ischaemic stroke. Karolinska Stroke Update Consensus Statement 2002. Available from: http://www.strokeupdate.org/ALLCURRENT/Consensus/Consensus_2002/Cons_thrombolysis_2002.htm Accessed 27 January 2009