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DaTSCAN™ (Ioflupane I 123 Injection) Recommended in Updated European Guidelines for Diagnosis of Alzheimer's Disease
Date:10/14/2010

PRINCETON, N.J., Oct. 14 /PRNewswire/ -- GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced that DaTSCAN™ (ioflupane I 123 injection), a radiopharmaceutical agent intended for use with single photon emission computed tomography (SPECT) imaging of the brain, has been recommended in updated European Federation of the Neurological Societies (EFNS) guidelines for the diagnosis and management of Alzheimer's disease (AD). The guidelines appear in the October issue of the European Journal of Neurology.(1)

Specifically, the guidelines, which were last issued in 2007(2), note that SPECT "may increase diagnostic confidence in the evaluation of dementia," adding that dopaminergic SPECT imaging with DaTSCAN is useful in differentiating AD from dementia with Lewy bodies (DLB)(1), a neurological condition that is similar to AD in that it results from the death of nerve cells in the brain.(3) The EFNS recommendation carries a level A grade of evidence – the strongest grade assigned in the guidelines – noting that DaTSCAN can differentiate AD from DLB with sensitivity and specificity of "around 85%."(1,2)

"As the global population ages and the prevalence of dementia rises, it will become increasingly important to be able to differentiate Alzheimer's disease from other types of dementia," said Adrian Holden, EU Head of Medical Professional Services for GE Healthcare. "Neurologists will therefore become increasingly reliant on imaging technologies that can accurately yield a definitive diagnosis. We are pleased that the EFNS has recognized the value of DaTSCAN in facilitating diagnosis of dementia, particularly with regard to distinguishing Alzheimer's disease from dementia with Lewy bodies. We hope the EFNS recommendation results in enhanced provision of timely and appropriate treatment to patients living with dementia – not only in Europe, but worldwide."

Dementia is a general term for a group of symptoms – such as loss of memory, impaired judgment, language difficulty, loss of complex motor skills, and other cognitive dysfunction – resulting from permanent damage or death of the brain's nerve cells.(4) An estimated 24 million people around the world – including 5.4% of those aged 65 or older – are living with dementia; this figure is expected to double every 20 years to 42 million by 2020 and to 81 million by 2040. Of those living with dementia, 60% live in developing countries; this percentage is expected to rise to 71% by 2040.(5)

AD is the most common cause of dementia, representing about 60% of all dementias.(4) An estimated 8.45 million people in Europe and 5.1 million people in the United States are thought to be living with AD.(6,7) DLB, which is estimated to account for 10-20% of dementias(8), takes its name from the abnormal collections of protein, known as Lewy bodies, in the nerve cells of the brain.(3)

"By specifically mentioning the utility of dopaminergic SPECT brain scanning (DaTSCAN) in differentiating Alzheimer's disease from dementia with Lewy bodies in their new guidelines, the EFNS Scientist Panel on Dementia has underscored the importance of functional (SPECT) neuroimaging in the diagnostic work-up of patients with dementia," commented John O'Brien, one of the authors of the guidelines and Professor of Old Age Psychiatry at the Institute for Ageing and Health at Newcastle University in Newcastle upon Tyne, U.K. "A timely and accurate diagnosis of dementia provides certainty for patients and their carers, can reduce their anxiety and allows them to better plan for the future and understand the symptoms they are experiencing. Early diagnosis is important as it can improve utilization of healthcare resources and contribute to improved long-term patient outcomes, while also potentially reducing the use of inappropriate medications that can sometimes have serious side effects."

DaTSCAN was granted a Marketing Authorization by the European Commission in July 2000 for use in detecting loss of functional dopaminergic neurons (nerve cells in the brain) in patients with clinically uncertain Parkinsonian syndrome (PS). In July 2006, the European indication was expanded to include differentiation of probable DLB from AD. DaTSCAN is currently licensed and distributed in 32 countries, and has been in clinical use for ten years in more than 300,000 patients worldwide.(9,10)

In March 2009, GE Healthcare submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for DaTSCAN for striatal dopamine transport (DaT) visualization in the brain of adult patients with suspected PS. Dopamine is a brain chemical that is classified as a neurotransmitter and is found in regions of the brain that regulate movement, emotion, motivation, and pleasure. Due to an unmet clinical need for an imaging agent to assist physicians in managing patients according to their dopaminergic status, GE Healthcare was granted "Priority Review" of the DaTSCAN NDA.(9)

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our web site at www.gehealthcare.com.

(1) Hort J, O'Brien JT, Gainotti G, et al. EFNS guidelines for the diagnosis and management of Alzheimer's disease. Eur J Neurol 2010;17(10):1229-1235.

(2) Waldemar G, Dubois B, Emre M, et al. Recommendations for the diagnosis and management of Alzheimer's disease and other disorders associated with dementia: EFNS guideline. Eur J Neurol 2007;14:e1-e26.

(3) Dementia with Lewy bodies. Alzheimer's Disease International Web site. http://www.alz.co.uk/alzheimers/lewy.html.  Updated November 20, 2007. Accessed September 30, 2010.

(4) About dementia. Alzheimer's Foundation of America Web site. http://www.alzfdn.org/AboutDementia/definition.html.  Accessed September 30, 2010.

(5) Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet 2005;366:2112-2117.

(6) Packo I. Dementia in Europe Yearbook 2008. Luxembourg: Alzheimer Europe, 2008.

(7) About Alzheimer's – statistics. Alzheimer's Foundation of America Web site. http://www.alzfdn.org/AboutAlzheimers/statistics.html.  Accessed September 30, 2010.

(8) Dementia with Lewy bodies. MedScape eMedicine Neurology Web site. http://emedicine.medscape.com/article/1135041-overview. Updated December 23, 2009. Accessed August 30, 2010.

(9) Transcript from Peripheral and Central Nervous System Advisory Committee Meeting, August 11, 2009. Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 2009. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM191398.pdf.  Accessed October 12, 2010.

(10) Data on file. GE Healthcare.


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