Lilly imaging drug fails to win FDA panel's backing

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Eli Lilly and Co. failed to win a U.S. panel’s backing for a new drug to help identify plaque in the brain tied to Alzheimer’s disease.

Lilly’s Amyvid isn’t ready to be approved to detect beta-amyloid plaque deposits in the brain, outside advisers to the Food and Drug Administration said Thursday in a 13-3 vote at the agency’s headquarters in Silver Spring, Md. The panel unanimously agreed that the medicine can be approved if Lilly establishes a training program and a way to ensure that the results of brain scans are read consistently.

Lilly, based in Indianapolis, acquired Amyvid in its $300 million purchase of closely held Avid Radiopharmaceuticals in December. While the FDA usually follows the recommendations of its advisory panels, it isn’t required to do so.

“We appreciate the careful and thoughtful review of our data today by the committee,” said Daniel M. Skovronsky, chief executive officer of Lilly’s Avid subsidiary, in a statement. “We are encouraged that they recommended a clear path toward approval.”


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