GE Healthcare ($GE) moved ever-so-close this week to the regulatory finish line for flutemetamol, a PET imaging agent designed to help diagnose Alzheimer's disease. The FDA in the U.S. and regulators in Europe both accepted the company's approval application for consideration.
The move to consider approval applications in both regions almost simultaneously is highly unusual. Jonathan Allis, GE Healthcare's general manager for positron emission tomography in the company's medical diagnostics division, spoke to FierceMedicalDevices at the J.P. Morgan Healthcare Conference in San Francisco about the milestone. He called it a significant step, representing the culmination of "many year's hard work."
"It's huge," he told us. "Flutemetamol is one part to the approach of [Alzheimer's treatment]. But it is a big part."
Clinicians inject flutemetamol into patients before PET scans, and the substance is drawn to amyloid deposits in the brain--which are considered to be key indicators of Alzheimer's disease. And regulatory filings became a certainty in September, when the company touted positive Phase III results. The study, involving 180 end-of-life patients detected beta amyloid with a 75% to 100% median sensitivity--and a 99% to 100% specificity.
Flutemetamol's entry into the marketplace would be a big advance in Alzheimer's diagnosis, considering beta amyloid buildup is currently confirmed only in post-mortem studies. GE Healthcare has also licensed the imaging agent to Merck ($MRK) to support the company's development of MK-8931, a potential Alzheimer's drug. A similar deal is in place with Johnson & Johnson ($JNJ) and a third unnamed company.
- read the release
Related Articles:
GE licenses Alzheimer's imaging agent to Merck
GE touts promising PhIII for Alzheimer's imaging agent
Merck turns to GE agent to track potential Alzheimer's biomarker
Merck ignores red flags and throws dice on PhII/III Alzheimer's gamble