Lilly Alzheimer’s diagnostic approved for use in EU

Hannah Blake

pharmaphorum

Eli Lilly and its subsidiary, Avid Radiopharmaceuticals, have announced that the European Commission has approved Amyvid (Florbetapir (18F)) solution for injection as a diagnostic radiopharmaceutical. The indication of this solution is for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment, who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.

Confirming the presence or absence of beta-amyloid plaques in patients with cognitive impairment is important because there are many possible underlying causes, including AD, neurological disorders, blood vessel-related disorders causing vascular dementia, movement disorders, brain tumors, normal pressure hydrocephalus and infections such as HIV.

"Amyvid is the first and only diagnostic tool approved for use in the European Union that can show the presence or absence of beta-amyloid neuritic plaque density in the brain. Amyvid, along with clinical evaluation, may be an important tool to help physicians who are managing patients with cognitive impairment. This is important because it is estimated that one in five patients clinically diagnosed with Alzheimer's disease during life were ultimately misdiagnosed and do not exhibit Alzheimer's disease pathology upon autopsy."

Diane Bakaysa, Amyvid global brand development leader at Lilly.

Amyvid will be available in the second quarter of 2012, initially only in select areas within the EU. Between now and when Amyvid is available, imaging centers will be able to prepare to place and receive orders for Amyvid on behalf of patients, as well as for Lilly to pursue reimbursement options in the European marketplace.

Alzheimer’s disease is the most common form of dementia, which causes progressive decline in memory and other aspects of cognition. Approximately 35.6 million people worldwide currently have dementia, with an estimated 7.7 million new cases each year, according to Alzheimer’s Disease International.

The US regulatory body, the FDA, approved Amyvid for use in the United States in April 2012.

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