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Apr 9, 2012

FDA Clears Avid’s Amyloid Plaque Imaging Agent for Aiding Alzheimer Disease Diagnosis

  • FDA approved Avid Radiopharmaceuticals’ Amyvid™ (florbetapir F 18 injection) radiolabelled diagnostic imaging agent for Alzheimer disease (AD). Avid is owned by Lilly, and its lead product Amyvid is designed to bind to amyloid plaques and be imaged in PET scans. A positive scan following administration indicates that amyloid plaques are present in the brain, increasing the possibility that cognitive impairment in the patient is due to Alzheimer disease.

    Amyvid is designed for use in parallel with other diagnostic criteria. U.S. clearance of the imaging agent was based on data from three clinical studies in healthy adult volunteers, patients with a range of cognitive disorders, and post-mortem brain tissue from terminally ill donors. Images from Amyvid brain scans are interpreted by either trained staff in person, or using electronic media-based resources.

    Data from two of the studies indicated that Amyvid PET demonstrated a median sensitivity of 92% and median specificity of 95% when interpreted by personally trained readers, and a median sensitivity and specificity of 82% and 95%, respectively, when evaluated by readers trained using electronic media.

    Lilly bought Avid in December 2010 for $300 million in cash, and potentially another $500 million in regulatory and commercial milestones relating to florbetapir. 

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