GE Healthcare is picking up the baton in a bid to get an imaging agent approved that could help in Alzheimer's diagnosis. The division of megaconglomerate General Electric ($GE) is touting positive early results from two Phase III studies of its imaging agent flutemetamol.
The news comes days after competitor Eli Lilly ($LLY) gained limited regulatory approval for a rival product. Lilly had previously failed to gain FDA approval to use it as a diagnostic aid specifically for Alzheimer's.
GE's flutemetamol is meant to work with PET scanning. After studying the brains of terminally ill patients who had agreed to undergo a brain autopsy, the company said its results show a strong connection between images generated by the flutemetamol-related PET images and pathology pointing to Alzheimer's disease-related beta amyloid plaque.
In another test involving healthy volunteers younger than 40, the company said the imaging agent consistently showed there wasn't any brain amyloid plaque. Full details are expected later this year, but GE said both studies met their primary endpoints.
Beta amyloid plaque in the brain indicates neuron degeneration and is thought to be one of the key indicators for Alzheimer's disease. A post-mortem brain autopsy is currently the only surefire way to obtain a definitive Alzheimer's diagnosis. A diagnostic tool that firmly establishes Alzheimer's in a living patient could lead to quicker and more preemptive treatment.
But amyloid plaque can also indicate some other neurodegenerative condition, so GE could face trouble gaining approval for a full Alzheimer's diagnostic indication. Lilly encountered a similar problem with its radioactive diagnostic agent Amyvid; in fact, the company was hit with an initial FDA rejection to use it as an Alzheimer's diagnostic tool. The agency finally blessed it last week as a diagnostic agent for possible Alzheimer's patients, but Amyvid is not approved as a definitive diagnostic tool.
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