GE Healthcare ($GE) is embroiled in the race for next-gen Alzheimer's imaging, and the company is trumpeting positive Phase III results for its flutemetamol agent.
GE's agent is designed to detect beta amyloid deposits in the brain, a biomarker for future Alzheimer's development, and is injected into patients before PET scans. In a study of 180 end-of-life patients, flutemetamol detected beta amyloid with a median sensitivity ranging from 75% to 100% and specificity ranging from 99% to 100%, GE reported.
Currently, beta amyloid accumulation is confirmed in post-mortem studies, and GE's agent will give physicians a chance to detect the Alzheimer's biomarker before it's too late, said GE diagnostics chief Jonathan Allis. "We know that Alzheimer's disease-related biomarkers such as beta amyloid may appear decades before clinical symptoms are observed, and the results from these studies demonstrate the potential of flutemetamol to detect such biomarkers in living patients," Allis said in a statement.
GE says the Phase III results are more than enough to demonstrate flutemetamol's merit, and the company plans to file for FDA and EU approvals later this year.
But the company is hardly alone in its quest for next-generation imaging for the disease. Navidea ($NAVB) is moving into Phase II for AZD4694, an imaging agent that also targets beta amyloid. Eli Lilly ($LLY) is trying to get Amyvid, its diagnostics agent, indicated for Alzheimer's imaging, but the FDA approved it only for use in identifying brain plaque buildup.
- read GE's release
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