SNM commends FDA Advisory Committee recommendation for florbetapir approval

Society of Nuclear MedicineJan 25 2011

PET scans deemed promising for earlier diagnosis

The Society of Nuclear Medicine (SNM) commends the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee on its recent recommendation for conditional approval of a new imaging agent, florbetapir. The agent, which is used in conjunction with positron emission tomography (PET) scans to detect beta amyloid plaques of the brain which may cause Alzheimer's disease, is produced by Eli Lilly and Company under the name Amyvid.

"For many years, the in vivo diagnosis of Alzheimer's disease has been a process of exclusion of other disorders that may affect cognition," said Karl Herholz, MD, president of SNM's Brain Imaging Council. "Now, for the first time, PET scans utilizing florbetapir will provide disease-specific inclusion criteria in the in vivo diagnosis of the disease."

PET scans performed with florbetapir will allow physicians to provide prognostic information to patients and their families even at a time of limited therapeutic approaches to treat Alzheimer's disease. In addition, the availability of imaging agents that can reliably detect amyloid plaques will be an absolute prerequisite to select patients that may benefit from future specific anti-amyloid based Alzheimer therapies.

"This recommendation of florbetapir is a huge step forward for the field of molecular imaging," noted Carolyn J. Anderson, PhD, president of SNM's Center for Molecular Imaging Innovation and Translation. "Researchers are continually working to advance the adoption of emerging molecular imaging technologies and probes in preclinical and clinical applications. It's wonderful to see molecular imaging playing such an important role in the molecular characterization of Alzheimer's disease. We are hopeful that this sets the stage for the approval of the many other molecular imaging agents for cancer, cardiovascular disease and other neurological diseases that are currently in clinical trials."

The FDA advisory committee approved florbetapir by a vote of 16-0 on the condition that training is provided to ensure physicians read the PET scans consistently and correctly. SNM and its Brain Imaging Council, in collaboration with other professional societies, are committed to developing PET imaging procedure guidelines and diagnostic scan interpretation educational tools to ensure that nuclear medicine physicians and radiologists will be proficient in performing and interpreting PET scans used in the diagnosis of Alzheimer's disease.

The FDA may or may not accept the opinion of the advisory committee.