Eli Lilly ($LLY) is on the verge of gaining approval in the European Union to use its radioactive diagnostic agent Amyvid as a tool to detect Alzheimer's related brain plaque buildup, 6 months after U.S. regulators granted a similar approval.
Reuters reports that the European Medicines Agency recommends approving Amyvid as a tool toward assisting in diagnosing Alzheimer's. Amyvid is an imaging agent that is drawn to beta amyloid proteins, something that builds up in excess in Alzheimer's patients' brains and is ultimately damaging to cognition and memory. After Amyvid binds to the protein, it enables the plaque to light up through a PET scan.
The European Commission will make a final approval decision, likely within three months, CBS News reports.
In April, the FDA approved Amyvid's use with PET scans to ferret out beta-amyloid plaque in the brains of live patients. It's not approved as a specific Alzheimer's diagnostic, but rather for patients suspected of having Alzheimer's or other cognitive decline conditions. Beta amyloid proteins can be involved in other neurodegenerative diseases. CBS notes that the proteins can be present in an older person's brain and not necessarily affect cognitive function. The best way that exists so far to definitively make an Alzheimer's diagnosis remains an autopsy.
- read the Reuters story
- here's CBS News' take