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ARTICLE | Regulation

Amyvid's yellow brick road

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

January 24, 2011 8:00 AM UTC

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...