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12:00 AM
Jan 24, 2011
 |  BioCentury  |  Regulation

Amyvid's yellow brick road

FDA panel draws up requirements for Lilly's Amyvid beta amyloid imaging agent

The first PET imaging agent for beta amyloid received a mixed review at an FDA panel meeting last week. Due to concerns about how the PET images were read and interpreted, the agency and panelists felt Amyvid florbetapir from Eli Lilly and Co. was not ready for approval.

But the Peripheral and Central Nervous System Drugs Advisory Committee did vote 16-0 that the agent would be ready for approval once the company implements a reader training program and demonstrates reader consistency in subjects who represent the patient population that would ultimately undergo Amyvid imaging.

Based on the discussion at the panel meeting, Lilly could accomplish those tasks using images from previous trials if it shows that readers can interpret images with consistency. Indeed, Lilly's Avid Radiopharmaceuticals Inc. subsidiary, which is developing Amyvid, is already taking the steps the panel recommended.

Ruling out is in

Current diagnostic methods for Alzheimer's disease have a historical false positive rate of 16%, which means tens of thousands of people are treated for AD when they actually have some other condition, like depression or vascular dementia. Definite diagnosis is possible only postmortem using histopathology to look for beta amyloid plaques in the brain.

The ability to image beta amyloid in patients' brains while they are alive thus would have a clinical benefit. The problem is beta amyloid is often present in the brain of patients who have normal cognition, especially elderly patients.

Instead of asking FDA for approval based on a positive scan, Avid asked for approval of Amyvid to detect beta amyloid aggregates in the brain, with a negative scan as "clinically useful in ruling out the presence of pathologically significant levels of beta amyloid in the brain."

The company's Phase III A07 trial was the only pivotal trial. A07 had two cohorts: an autopsy cohort to correlate Amyvid images with the gold standard of postmortem histopathology of beta amyloid; and a young cognitively...

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