Avid's diagnostic aid for Alzheimer's gets FDA approval

By Linda Loyd

A radioactive compound that lights up plaques in the brain to help diagnose Alzheimer's disease has been approved by the Food and Drug Administration for use in patients being evaluated for Alzheimer's and other causes of cognitive decline.

The imaging agent, Amyvid, was developed by a Philadelphia biotech start-up, Avid Radiopharmaceuticals Inc., now owned by Eli Lilly & Co. It can show amyloid deposits in the brain that are visible on positron-emission tomography (PET) scans. The product got the green light late Friday and will be available in June.

Spun out of research at the University of Pennsylvania, Avid was bought in November 2010 by Eli Lilly for an initial $300 million. The deal called for an additional $500 million if certain commercial and regulatory milestones were reached, including FDA approval of the chemical known as florbetapir F 18 injection.

The dye binds with plaques that are a marker of Alzheimer's disease and that have been studied in several thousand people and in three clinical studies.

"We're excited. The approval means that this product will finally be available to the patients who need, and can benefit from, this," said Avid Radiopharmaceuticals' founder and chief executive officer, Daniel Skovronsky, 39, a Penn neuropathologist.

"The type of patient who will benefit from this test are people who have symptoms of cognitive decline, such as memory loss," he said. "A physician can order the scan, and it will give them information about the presence, or absence, of amyloid plaques in the brain."

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