January 21, 2011 — The U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee decided that it could not recommend approval of Amyvid (florbetapir) at this time based on the currently available data (13-3); but, voted unanimously (16-0) to recommend approval of Amyvid conditional on a reader training program that demonstrates reader accuracy and consistency through a re-read of previously acquired scans. The committee said efficacy was established and there were no significant safety concerns raised.
Amyvid is an imaging tool indicated for positron emission tomography (PET) imaging of beta-amyloid plaque in the brain. It is being investigated for the potential use in ruling out Alzheimer's disease. In addition to the pivotal phase III "Image-to-Autopsy" study, other clinical studies are also being conducted in the European Union., North and South America, Australia and Asia. The committee stated that a negative scan would be clinically useful in indicating that Alzheimer's pathology is unlikely to be the cause of a patient's cognitive decline.
Lilly acquired Avid Radiopharmaceuticals Inc. in December 2010. Amyvid is Avid's lead candidate and was the first beta-amyloid imaging compound to enter multi-center, investigational new drug (IND) clinical studies in the United States. Amyvid was recently assigned priority review designation by the FDA.
The FDA will consider the panel's recommendation in its review of Amyvid. The FDA takes the advice of its advisory committees into consideration when reviewing investigational drugs, but is not bound by their recommendations.
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