FDA Committee Says Cannot Recommend Amyvid Approval On Currently Available Data

Eli Lilly & Co. (LLY) Thursday said the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee decided that it could not recommend approval of Amyvid or florbetapir at this time based on the currently available data. However, it voted 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 supported that efficacy was established and there were no significant safety concerns raised.

Amyvid is a molecular imaging tool under investigation for the detection of beta-amyloid plaque in the brain. 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. Amyvid was recently assigned priority review designation by the FDA.

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