Tuesday, January 25, 2011

FDA Panel Backs Amyvid (Florbetapir) Approval

FDA approve a new chemical, Florbetapir, E)-4-(2-(6-(2-(2-(2-([18F]-fluoroethoxy)ethoxy)ethoxy)- pyridin-3-yl)vinyl)-N-methyl benzenamine (see structure) that can highlight the telltale signs of Alzheimer's in brain scans may one day help doctors diagnose the neurodegenerative disease, experts said. Amyvid (trade name), with one critical caveat, however manufacturer Eli Lilly and Co. must demonstrate that standards for interpreting brain scans that show amyloid plaques illuminated by Amyvid can be made consistent enough to routinely guarantee an accurate diagnosis.

Amyvid (florbetapir) is injected into patients who then undergo a PET scan; a negative result can help rule out Alzheimer's, according to Lilly. Experts agreed that the test could become a critical part of spotting Alzheimer's before symptoms have taken hold, but they noted that the clinical reality of that is far from imminent.
    "It may well be that amyloid imaging will join colonoscopy, mammography, etc. as mid-life surveillance tests, and that anti-amyloid interventions are most effective in the pre-symptomatic stages of Alzheimer's disease," said Dr. Sam Gandy, the Mount Sinai Chair in Alzheimer's Disease Research in New York City. However, this possibility is years away, he added..............

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