I will be at this advisory board tomorrow and will provide update afterward...
WSJ BUSINESS JANUARY 19, 2011 FDA Skeptical About Detecting Alzheimer's
Article by JENNIFER CORBETT DOOREN
Food and Drug Administration staff cast a skeptical eye on an Eli Lilly & Co. imaging drug designed to detect the plaques in the brain that are characteristic of Alzheimer's disease, offering a first glimpse of how regulators view the burgeoning field of Alzheimer's diagnosis.
While the agency said the drug found plaques successfully most of the time, FDA reviewers questioned whether there's any real-world use for such a test in a disease that has no cure.
Two FDA reviewers recommended against approving the product, called Amyvid. One wrote that "although no significant risks associated with the use of Amyvid have been identified, no convincing evidence...has been demonstrated either." The agency noted there isn't any approved treatment that "consistently delays or reverses" Alzheimer's disease once diagnosed.
Dan Skovronsky, founder of the small company that developed Amyvid, said that if it were approved, doctors could use it to help rule out Alzheimer's disease because a negative scan would suggest a person doesn't have the classic trait of the disease.
"We think we have a tool that's very effective," he said.
The area of Alzheimer's diagnosis has attracted the interest of several large companies including Bayer AG and GE Healthcare, a unit of General Electric Co. Lilly is potentially the furthest along with the development of a plaque-imaging drug after acquiring Mr. Skovronsky's company, Avid Radiopharmaceuticals Inc., last month for an initial payment of $300 million.
Lilly is seeking FDA approval to market Amyvid as an agent to detect beta-amyloid, a protein contained in clumps or plaques seen in the brains of people who died of Alzheimer's complications. The company isn't directly calling it a way to diagnose Alzheimer's. Scientists aren't sure if the clumps are a cause or symptom of the disease.
Amyvid, also known by its generic name florbetapir, is designed to be used in patients undergoing positron-emission tomography scans in order to "light up" areas of the brain that contain beta-amyloid.
A panel of FDA advisers will further review the agent Thursday. The first question they are being asked to address is whether knowledge of brain amyloid plaque would have "clinical usefulness."
Some researchers already use PET scans to study Alzheimer's, but FDA approval of an imaging agent would likely make such tests more generally available to patients suspected of having Alzheimer's.
The key study involving Amyvid that figured in the FDA initial review looked at 29 patients considered near the end of life. After they died and had their brains examined in an autopsy, 15 were judged to meet the criteria for Alzheimer's disease, and 14 of those had scans that were positive for amyloid before they died.
Autopsies suggested 14 of the 29 didn't have Alzheimer's, and all had negative scans. The findings are being published in this week's Journal of the American Medical Association.
Currently, suspected Alzheimer's is diagnosed using a series of cognitive tests to show how well a patient's mind is functioning. The disease can't be formally diagnosed until an autopsy.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
