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GE: PET imaging agent flutemetamol shows promise in phase 3 trials

by Brendon Nafziger, DOTmed News Associate Editor | July 18, 2012
This spring, Eli Lilly & Co.'s Amyvid became the first PET imaging agent ever approved by the Food and Drug Administration to help doctors measure beta-amyloid plaque deposits in the brains of living patients who might be suffering from Alzheimer's disease.

The Eli Lilly drug was the first, but it almost certainly won't be the last. And news from the big Alzheimer's conference taking place this week suggest GE Healthcare has moved much closer to getting its own PET drug out the door.

On Tuesday, GE released final results from a phase 3 study on its own PET imaging agent, flutemetamol. According to GE, the drug was able to accurately measure beta-amyloid deposits in living patients when compared against pathological data taken from later autopsies on the same people.

The company announced the results, which will be the basis of a Food and Drug Administration application later in the year, at the Alzheimer's Association International Conference in Vancouver. Preliminary results from the phase 3 studies were first released in April.

In the study, researchers compared flutemetamol PET scans of 68 terminally ill Alzheimer's patients with later post-mortem brain examinations. GE said the beta-amyloid load found on PET scans with the drug matched up to plaque presence when the brains were later studied in the lab.

According to a GE press release, the majority of readers could accurately classify amyloid-positive brains as abnormal 86 percent of the time. Specificity was 92 percent.

From the wording of the release, it seems GE is positioning flutemetamol to function in the clinical workflow in a similar way to Amyvid. That is, it wouldn't be marketed to diagnose Alzheimer's, which today can really only be done after death using the "gold standard" histopathological examination, but rather it could help doctors rule out the incurable brain-wasting disease when patients show up with unexplained cognitive troubles.

It should be noted this isn't GE's only Alzheimer's diagnostics gambit. The company also announced last month it was teaming up with the VTT Technical Research Center of Finland to study serum biomarkers that would indicate the presence of the disease.

Note: an earlier version of this article incorrectly stated when Amyvid was approved. We apologize for the error.

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