The FDA has approved Piramal Imaging’s molecular imaging agent Neuraceq, just four weeks after it received approval from the European Commission, the Swiss company said Thursday.
The injectable drug 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 approval stems not only from safety data from 872 patients who took part in clinical trials of Neuraceq (Florbetaben F18) around the world, Piramal said, but also from three studies that looked at images of brains from adults with a range of cognitive function.
More than 200 patients made end-of-life decisions to donate their brains, 82 of which demonstrated Neuraceq’s efficacy in detecting moderate to frequent β-amyloid neuritic plaque.
Neuraceq’s risk management summary was recently released by the European Medicines Agency, as part of a recent effort to bolster its transparency relating to approved drugs. The report outlines Neuraceq’s treatment benefits, as well as risk factors.
Piramal partner IBA Molecular will manufacture and distribute Neuraceq, the company said. Piramal spokeswoman Emily Fisher told Drug Daily Bulletin the compound is on track for commercialization in both the U.S. and Europe by the second or third quarter of this year. — Lena Freund
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