FDA approves Neuraceq amyloid PET agent

F-18 florbetaben, also known as Neuraceq, received U.S. Food and Drug Administration (FDA) approval today as a diagnostic amyloid agent to help rule out Alzheimer’s disease.

The news comes on the heels of the agent’s European Commission green light a month ago to market the drug in Europe. The PET agent is used to approximate the density of amyloid plaque in the brain for cognitively impaired patients suspected to be developing Alzheimer’s disease and other neurodegenerative disorders.

This is the third amyloid agent to procure FDA approval. The other approved agents are F-18 florbetapir (Amyvid), approved in 2012, and F-18 flutemetamol (Vizamyl), approved last fall.

Makers of Neuraceq, Piramal Imaging, a subsidiary of India-based Piramal Enterprises, have released a statement on the approval and cite a statistic from the American Psychiatric Association, which estimates that somewhere between 10-30 percent of Alzheimer’s diagnoses are incorrect.

“Alzheimer's disease or any form of cognitive impairment is a daunting diagnosis," said director of the board for Piramal, Ludger Dinkelborg, PhD. "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."

Dementia is expected to affect 135 million people across the world by 2050, according to 2013 data from Alzheimer’s Disease International, taking into account new research regarding cases throughout Asia and Sub-Saharan Africa. The Alzheimer’s Association estimates that Alzheimer’s disease comprises about 60-80 percent of all cases of dementia.  

The Centers for Medicare & Medicaid Services currently covers a single amyloid PET scan per patient under Coverage with Evidence Development in mandated clinical trials.

Piramal is collaborating with IBA Molecular in order to manufacture and distribute the agent among the latter’s network of 49 PET isotope facilities.