Thursday, January 20, 2011

FDA: PCNS Drugs Advisory Committee Results for Avid's Amyvid Alzheimer's Amyloid Neuroimaging Agent

From The New York Times:

F.D.A. Sees Promise in Alzheimer’s Imaging Drug
Published: January 20, 2011
Filed at 5:40 p.m. EST
WASHINGTON (AP) — A federal panel of medical experts said Thursday a first-of-a-kind imaging chemical designed to help screen for Alzheimer's disease could be useful pending additional study and training for physicians.

The Food and Drug Administration panel of advisers voted 16-0 in favor of approval for Eli Lilly's Amyvid on the condition that the company demonstrates the images can be consistently interpreted by physicians who have received training in reading the scans.

Without those requirements the panel voted 13-3 against approval for the injection in an earlier vote. The FDA is not required to follow the panel's advice, though it often does.

Read the full report

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