03:30pm Tuesday 19 September 2017

SNM Applauds FDA Advisory Committee Recommendation for Approval of Alzheimer's Disease Imaging Agent

Reston, Va. — 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.

To schedule an interview with an SNM expert, please contact Susan Martonik at (703) 652-6773 or smartonik@snm.org.

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About SNM—Advancing Molecular Imaging and Therapy

SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today’s medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.

SNM’s more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit http://www.snm.org.


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