FDA Approves Neuraceq for PET Imaging of the Brain

The U.S. Food and Drug Administration (FDA) announced today its approval for Neuraceq, which is indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in cognitively impaired adult patients being evaluated for Alzheimer’s disease or other cognitive decline.

There are over seven million new cases of dementia each year worldwide, with Alzheimer’s disease accounting for 60 percent to 80 percent of all dementia diagnoses. Studies have shown that Alzheimer’s gets incorrectly diagnosed in 10 percent to 30 percent of cases, leaving many patients without appropriate treatment.

The Centers for Medicare and Medicaid Services has stated it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development programs, which aim to assess the impact of beta-amyloid scans on improving patient outcomes or advancing treatment options. Beta-amyloid is the primary indicator of Alzheimer’s.

The FDA approval was based on safety data from 872 patients who participated in global clinical trials, and three studies that examined images from adults with a range of cognitive function. The studies included 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and could be useful in estimating the density of these plaques in life.

Neuraceq is manufactured by Piramal Imaging, a division of Piramal Enterprises, Ltd.