FDA approves PET agent to assess beta-amyloid plaque density

The FDA has approved a new agent for the analysis of beta-amyloid neuritic plaque density in cognitive-impaired adult patients under evaluation for Alzheimer’s disease.

Neuraceq™, brand name for 18F-florbetaben, was developed by Piramal Imaging, Berlin, which received marketing authorization for the agent from the European Commission last month.

Last July, CMS ruled that it would reimburse providers enrolled in approved clinical studies for a single beta-amyloid PET scan per patient with suspected Alzheimer’s disease under its coverage with evidence decision program. In its announcement, Piramal Imaging cited American Psychiatric Association guidelines estimating that 10% to 30% of Alzheimer’s disease diagnoses are incorrect upon post-mortem histological investigation.

“Alzheimer's disease or any form of cognitive impairment is a daunting diagnosis,” said Ludger Dinkelborg, Ph.D., director of the board, Piramal Imaging, in the announcement. “For the patients and caregivers, the concern centers around understanding what the future holds. For physicians, the challenge is properly assessing the patient and determining the best care path."

Piramal Imaging, with offices in Berlin, Boston, and Matran, Switzerland, was created when Mumbai, India-based Piramal Enterprises acquired rights to the molecular imaging research and development portfolio of Bayer Pharma AG. IBA Molecular will manufacture and distribute 18F-florbetaben in the U.S. and Europe.

“The FDA's approval of Neuraceq™ is a significant milestone for Piramal Imaging and demonstrates our dedication to advancing innovation in molecular imaging globally,” said Swati Piramal, M.B.B.S., MPH, vice chairperson, Piramal Enterprises, Ltd, in a prepared statement. “The rising prevalence of Alzheimer's disease and cognitive impairment is being felt individually and collectively around the world. Our goal as a company is to usher in a new era of imaging that helps paint clearer pictures of the physiology of such conditions and helps improve patient outcomes.”