FDA approval for Neuraceq (florbetaben F18 injection)

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The US Food and Drug Administration (FDA) has approved Piramal Imaging’s Neuraceq (florbetaben F18 injection). This approval comes only four weeks after receiving marketing authorisation for Neuraceq from the European Commission.

Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

 


The Centers for Medicare & Medicaid Services has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development programmes. The objective of these programmes is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.

 


The FDA approval of Neuraceq is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation programme. Images were analysed 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 is a useful tool to estimate the density of these plaques in life.

 


Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq.