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Piramal's florbetaben accepted for FDA review

by Loren Bonner , DOTmed News Online Editor
Piramal Imaging SA is inching one step closer to getting its investigational PET amyloid imaging agent florbetaben approved for clinical use. The company announced last week that the U.S. Food and Drug Administration and the European Medicines Agency (EMA) will proceed with the review of florbetaben, an amyloid imaging agent used in the visual detection of beta amyloid in the brains of patients being evaluated for Alzheimer's disease and related cognitive disorders.

The news comes on the heels of GE's announcement earlier this year that its PET amyloid imaging agent, flutemetamol, was accepted for review by the FDA and the EMA as well. Eli Lilly and Co.'s Amyvid (florbetapir), is the only beta-amyloid imaging agent that has received FDA approval so far.

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Imaging agents such as these allow doctors for the first time to gauge plaque in the brain of living patients. However, beta-amyloid brain scans can only help doctors rule out Alzheimer's if the scans are negative for plaque deposits; the presence of plaque by itself is not grounds for an Alzheimer's diagnosis.

According to a statement from Piramal, the submission of florbetaben is based on the results of a broad clinical program including a pivotal multi-center phase III trial. The study confirmed that florbetaben binds to beta-amyloid in the brain at the regional level and is diagnostically useful on the subject to exclude Alzheimer's disease. The trial demonstrated 100% sensitivity and 92% specificity for the visual assessment procedure proposed for routine clinical practice.

At last year's Society of Nuclear Medicine and Molecular Imaging annual meeting, Dr. Ludger Dinkelborg, CEO and co-founder of Piramal, told DOTmed News that the phase III trial of florbetaben looked at six different regions of the brain, and incorporated MRI imaging in addition to PET.

"Because PET doesn't have a high spatial resolution, we combined this study with an MRI," he said.

Regional MRI-PET co-registered data were analyzed by three independent blinded readers.

"We now have data on all the regions of the brain and data on histochemistry showing: is the protein [amyloid] there? How much of the protein is there? And in the six regions are there differences?" said Dinkelborg.

Piramal Imaging SA, a division of the India-based Piramal Enterprises Ltd., was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG.

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