Exclusive: GE to soon seek FDA OK for Alzheimer's imaging agent
PARIS (Reuters) - General Electric Co is finishing clinical trials for an agent designed to detect early signs of Alzheimer's and expects to seek regulatory approval by year's end, its executive leading the process said.
GE, Eli Lilly and Co and Bayer AG are all developing similar compounds, which stick to amyloid plaques in the brain and light up on positron emission tomography or PET scans. If approved, the compounds will be used to help doctors rule out Alzheimer's in people.
Lilly unit Avid Radiopharmaceuticals was first to seek U.S. Food and Drug Administration approval for its tracer, called florbetapir or Amyvid, but was dealt a setback when the agency said it should develop training programs to ensure the tests are read in a consistent manner.
Jonathan Allis, general manager of PET Medical Diagnostics at GE Healthcare, told Reuters that his team plans to learn from the mistakes of its competitors.
In an exclusive interview at the Alzheimer's Association's International Conference in Paris, Allis described what he called a long game in identifying and treating the brain-wasting disease.
"I think our data is very good. It's tight. We're close to filing (for approval)," Allis said of GE's imaging agent, called flutemetamol.
"They (Avid) did a great job, but I think we did the boring stuff better," he said, referring to the company's extensive work on manufacturing, imaging quality and image analysis.
Radioactive tracers that test for fragments of beta-amyloid plaque are seen as a critical bridge in the search for effective drugs to treat Alzheimer's, a fatal, mind-robbing disease that affects nearly 36 million people worldwide.
Scientists believe these Alzheimer's-linked plaques start developing at least a decade before symptoms occur, and spotting those changes in the brain early offers the best chance to intervene with new drugs that might prevent or delay the disease.
Once they win approval for their products, GE, Lilly and Bayer will compete for market share. To gain an edge, GE is developing a software program to help analyze the flutemetamol scans, and it is developing magnetic resonance imaging (MRI) scans to measure brain volume, which also changes as Alzheimer's advances.
"By the time we launch next year, we'll launch the MRI images and combine the two together," Allis said.
Allis said GE has a growing interest in addressing Alzheimer's, a disease that is expected to affect as many as 115 million people by 2050 unless effective treatments are found.
"There is a huge interest in Alzheimer's and it goes right to the top of GE," Allis said, referring to GE Chief Executive Jeffrey Immelt, who once headed GE Healthcare Systems.
Besides amyloid imaging, GE plans to build on a partnership with Johnson & Johnson announced last December to search for other changes in the body that can be used to develop biomarker tests for Alzheimer's.
"That is the start of what we hope to be a much broader relationship with J&J in Alzheimer's disease," Allis said.
Allis says finding earlier ways to identify Alzheimer's patients is going to be critical as drug companies such as Lilly, Pfizer Inc and J&J look to test new agents that will stop the disease before it does too much damage.
Current medications treat Alzheimer's symptoms but cannot change the course of the disease, and new drugs that have been tried so far have failed, in large part, experts think, because they were tried only when the disease was too advanced.
"If you look at all the pharmaceutical trials now, they are all in probably the wrong patient group. They are too late," Allis said.
Amyloid imaging agents are already being commonly used to help drug companies identify people with amyloid in their brain who might be a good candidates for drug trials.
Allis said GE and J&J are trying to identify screening tests for the disease that can be used in a wider population, in much the same way people are tested for early signs of prostate cancer.
"It's a long game. I think we are not anywhere near the end," he said.
(Editing by Michele Gershberg and Steve Orlofsky)
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