Amyvid (Florbetapir F18) in injectable solution gets approval in the European Union for use in the diagnosis of patients with cognitive impairment Alzheimers disease and other causes.

Indianapolis (USA)UU), January 2013.- Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., wholly owned subsidiary of Lilly, have announced that the European Commission has approved Amyvid (Florbetapir F18) solution for perfusion as a radiopharmaceutical indicated diagnosis for PET (positron emission tomography) test that can identify the density of the plate beta-amyloid in the brain of adult patients neuritic with cognitive impairment, which is evaluating a possible diagnosis of Alzheimer’s disease and other causes of cognitive impairment. Amyvid should be used in conjunction with clinica1 evaluation. Amyvid joins the amyloid plaques, one of the characteristic neuropatologicas of the of Alzheimer disease (ad) (2,3,4) and detected using PET imaging of the brain.(1)

Amyvid is the first and only diagnostic tool adopted by the European Union showing the presence or absence of density of plaques of beta-amyloid in the brain neuritic ”, says Diane Bakaysa, international head of Amyvid Lilly. Amyvid, along with a clinical evaluation, can be an important aid to doctors who treat patients with cognitive impairment. It is important because it is estimated that one of every five patients diagnosed with Alzheimer’s disease based on clinical criteria were incorrectly diagnosed in life not being typical of Alzheimer’s pathologic findings to perform the autopsy ”. (5, 6)
Confirm the absence or presence of plates beta-amyloid in patients with cognitive impairment is important because there are many underlying causes, including EA, neurological disorders, disorders of the blood vessels that can cause a vascular dementia, disorders of the movement, brain tumors, hydrocephalus normal pressure, or infections like HIV.(7)

a negative scanner made with Amyvid indicates the presence of few or no amyloid plaque, a fact not consistent with the diagnosis of Alzheimer disease (ad). A positive scanner, indicates the presence of moderate to frequent of amyloid plaques, but does not establish if same a diagnosis of EA or other cognitive impairment since plates neuritic in gray matter may present asymptomatic form in elderly and also in some dementias neurodegenerative (EA(, dementia dementia due to Parkinson’s or Lewy bodies).

Amyvid images should only be interpreted by specialists trained in the interpretation of PET images with florbetapir (F18).1 initially, Amyvid will be available in selected areas within the European Union from the second quarter of 2013. The time between the approval of Amyvid and make available allows to image centers Amyvid orders for their patients, as well as to Lilly seek reimbursement options in the European market.

The Alzheimer’s disease (EA), the most common form of dementia, caused a progressive deterioration of memory and other aspects of cognition. The EA is a disease that causes between 60 and 80 per cent of cases of the Alzheimer’s Association demencia.4 ’ s Disease International (ADI) calculates that there are now 35.6 million people worldwide with dementia and 7.7 million new cases occur each year (which implies a new case every four seconds). It is estimated that it will affect more than 115 million people by the year 2050.(8)

Amyvid approval was based on data submitted by Lilly, between them, several clinical studies supporting the safety and technical results and diagnosis of Amyvid. In the study pivotal elderly at the end of his life were included in which the diagnosis made with Amyvid to detect the density of the plate cortical neuritic (none or little to moderate or frequent) was evaluated in 59 subjects who underwent a PET scanner with Amyvid and after his death neuropatologica biopsy was performed to assess in the brain post-mortem the tank plate beta-amyloid. In 59 individuals, a reading was made blind by five specialists in nuclear medicine who offered a majority reading of 92% sensitivity (95% CI: 78-98%) and specificity of 100% (95% CI: 80-100%). Sensitivity is the ability to correctly detect present moderate or frequent form plates; specificity is the ability to detect the few or the presence of plates. In a study with 47 young individuals (under 40), healthy, presumably free of beta-amyloid plaque, volunteers all PET scanners with Amyvid were negative.(1)

On Eli Lilly and Company

Lilly, a company based on innovation, is developing one growing portfolio of pharmaceutical products by applying the research more toe made both by its own laboratories around the world, such as through collaborations with prestigious scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers to some of the most urgent medical needs in the world through the supply of drugs and information. <? NS prefix = o ns = “urn: schemas-microsoft-com: Office” / >

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Referencia:

(1) Amyvid [package insert]. European Union. Eli Lilly & Co; 2013.

(2) Hyman BT, Phelps CH, Beach TG, et to the. National Institute on Aging – Alzheimer ’ of Association guidelines for the neuropathological assessment of Alzheimer’s ’ s Disease. Alzheimers Dement. 2012; 8: 1-13.

(3) myrrh SS, Heyman a., McKeel D, et al; and participating CERAD neuropathologists. The Consortium to Establish a Registry for Alzheimer’s ’ s Disease (CERAD): part II: standardization of the neuropathologic assessment of Alzheimer’s ’ s disease. Neurology. 1991; 41 (4): 479-486.

(4) Thies W, Bleiler L; Alzheimer ’ s Association. Alzheimer ’ of Association report: 2012 Alzheimer ’ s disease facts and figures. Alzheimers Dement. 2012; 8: 131-168.

(5) Lim A, Tsuang D, Kukull W, et to the. Clinical-neuropathological correlation of Alzheimer’s ’ of disease in a community – case series. J Am Geriatr Soc. 1999; 47 (5): 564-569.

(6) Petrovitch H, White LR, Ross GW, et to the. Accuracy of clinical criteria for AD in the Honolulu-Asia Aging Study, a population-based study. Neurology. 2001; 57 (2): 226-234.

(7) Dementia: Hope Through Research. National Institute of Neurological Disorders and Stroke (website). Last access: 13 November 2012.

(8) Alzheimer ’ s Disease International, World Health Organizatsion. Dementia: a public health priority. publication year: 2012. Last access: 15 November 2012.