FDA Approves Piramal Imaging’s NeuraceqTM (florbetaben F18 injection) for PET Imaging of Beta-Amyloid Neuritic Plaques in the Brain

Berlin/Boston, March 20, 2014 ‒ Piramal Imaging today announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq™. This approval comes only four weeks after receiving marketing authorization 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 (AD) and other causes of cognitive decline.

There are an estimated 7.7 million new cases of dementia each year worldwide.1 Alzheimer’s disease accounts for 60-80% of all dementia diagnoses.2 However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10-30% of cases.3

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

To read the full press release, please click here.

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