FDA Advisory Committee Provides Clear Path Forward For Development Of Amyloid Imaging Agents For Alzheimer's Disease

Main Category: Alzheimer's / Dementia
Article Date: 26 Oct 2008 - 0:00 PDT

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Avid Radiopharmaceuticals announced that the U.S. Food and Drug Administration (FDA) Peripheral and CNS Advisory Committee provided strong support for development of amyloid imaging agents to test for the presence or absence of Alzheimer's disease pathology in people with symptoms of cognitive impairment. Avid's Phase II amyloid imaging compound, 18F-AV-45 (AV-45) is well positioned to rapidly enter late stage development based on the FDA Advisory Committee recommendations.

"Today was a pivotal day for the entire Alzheimer's community, and a perfect example of the FDA and industry working together to successfully tackle a major public health challenge," said Daniel Skovronsky, M.D., Ph.D., CEO and President of Avid. "This was a significant and positive milestone for Avid and we are very pleased with the feedback received. We look forward to continuing to work closely with the FDA to move our Phase III clinical program forward."

"Rapid development of these agents is essential to catalyze trials for new therapies that may halt or even prevent Alzheimer's disease," said Michael Weiner, M.D. Professor of Radiology at the VA Medical Center, University of California San Francisco and the Principal Investigator of the Alzheimer's Disease Neuroimaging Initiative (ADNI). "Prior to this meeting, there were two major unanswered questions that could have impeded the further development of amyloid imaging. The FDA Advisory Committee today tackled both the issues of defining the clinical utility and of selecting the appropriate reference standard, thereby addressing these major obstacles to late stage development of amyloid imaging."

Avid's AV-45 was the first amyloid imaging compound to enter multi-center Phase II clinical studies in the United States and has now been studied in over 250 people, ranging from cognitively normal individuals to those with Alzheimer's disease. Avid is currently conducting clinical trials at over 25 research centers across the United States and anticipates initiating Phase III trials in early 2009. For more details please visit http://www.clinicaltrials.gov.

About Avid Radiopharmaceuticals Inc.

Based in Philadelphia, PA, Avid Radiopharmaceuticals Inc. is a leader in the development of products with the potential for earlier and more effective detection, diagnosis and monitoring of brain disorders. The company is a pioneer in the development of molecular imaging agents for Alzheimer's disease that could lead to earlier diagnosis and better evaluation of drugs designed to prevent or reverse amyloid plaque build-up in the brain. Avid is currently enrolling patients in clinical studies of 18F-PET agents for imaging amyloid plaques in Alzheimer's disease and for imaging the vesicular monoamine transporter (VMAT2) in diseases such as Parkinson's disease (PD), Dementia with Lewy Bodies (DLB) and Diabetes Mellitus (DM). More information about Avid is available at http://www.avidrp.com.

Avid Radiopharmaceuticals Inc.