FDA advisory panel today with Bayer, GE Healthcare on imaging biomarkers in Alzheimer’s will affect disease modification drug trials

Bayer, GE Healthcare and Avid Radiopharmaceuticals will meet with the FDA advisory panel today to discuss the development of new imaging markers for use in Alzheimer’s disease (AD). The Advisory Committee Meeting is aimed at providing specific recommendations based on clinical utility towards the design of Phase III diagnostic imaging studies in AD.

Two defining features of Alzheimer’s disease in the brain are amyloid plaques and neurofibrillary tangles, or tau. The plaques contain a protein called amyloid-beta, while the tangles are made of a protein called tau. The current, widely accepted amyloid hypothesis traces Alzheimer’s to plaque deposits, whereas the tau hypothesis links the disease to protein abnormalities.

There are some key concerns before approval of these imaging agents, several key opinion leaders said, including the validation of the binding properties of these new imaging agents to beta-amyloid, a key structural hallmark of this neurological disorder.

source: Financial Times

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