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Panel rejects Lilly Alzheimer's imaging agent

An advisory committee to the US FDA has voted against approval of Amyvid, developed by Lilly as a diagnostic tool to help rule out Alzheimer’s disease in patients experiencing cognitive decline

An advisory committee to the US Food and Drug Administration (FDA) has voted against approval of Amyvid (florbetapir), a molecular imaging tool being developed by Lilly as a diagnostic tool to help rule out Alzheimer's disease in patients experiencing cognitive decline.

The Peripheral and Central Nervous System Drugs Advisory Committee voted 13 to three to recommend that the FDA decline to approve the product based on the current data. However, the 16-member panel voted unanimously 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.”

Amyvid is designed to detect beta-amyloid plaque in the brain using Positron Emission Tomography. Lilly acquired the product when it bought Avid Radiopharmaceuticals late last year. Amyvid, which was recently assigned a priority review by the FDA, is Avid's lead candidate.

The advisory panel members' concerns echoed issues raised by FDA staffers in documents prepared in advance of the meeting that questioned whether technicians could accurately read the scans produced using Amyvid. Questions have also been raised by advisory committee members and FDA staffers about the usefulness of a diagnostic tool such as Amyvid even if it is accurate, given that there is no currently approved cure for Alzheimer's disease.

However, Avid CEO Daniel M Skovronsky put a positive spin on the outcome of the meeting. “We are encouraged that they recommended a clear path toward approval,” he said in a statement.

Amyvid has thus far been studied in more than a dozen trials enrolling 700 subjects ranging from cognitively normal individuals to those with Alzheimer's dementia, according to Lilly.

The FDA is not required to follow the advice of its advisory committees, but it frequently does so.

21st January 2011

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