An FDA advisory panel has recommended approval of a new imaging compound that can detect Alzheimer's brain plaques.
The process involves injecting a chemical called Amyvid, made by US pharmaceutical giant Eli Lilly, followed by an imaging scan that can detect plaque, or beta-amyloid aggregates, that indicate the presence of Alzheimer's.
AdvertisementThe FDA expert panel, whose rulings the FDA does not have to follow but typically does, first voted against (13 against and three in favor) recommending the test for approval in their meeting on Thursday.
But the panel inserted a condition that was not presented by the FDA -- that a training program would be implemented that shows accurate diagnosis can be made in the general population -- and approved that unanimously, 16-0.
Earlier this week, a study published in the Journal of the American Medical Association said the molecular imaging procedure could help lead to better treatment and diagnosis of Alzheimer's in living patients.
In that study, Christopher Clark of Avid Radiopharmaceuticals in Philadelphia, and colleagues examined whether florbetapir F 18 PET imaging (positron scanner) performed during life could accurately predict the presence of beta-amyloid, linked to Alzheimer's.
Accumulation of the protein, which can be seen in autospy, is believed to play a role in the disease by forming plaque in some areas of the brain.
The plaque ultimately destroys neurons, leading to irreversible brain degeneration.
There is no cure for Alzheimer's, which affects around five million Americans and 26 million people worldwide.