German pharmaceutical company Life Molecular Imaging Ltd (LMI) announced on Tuesday that the US Food and Drug Administration (FDA) has approved updated labelling for Neuraceq (florbeteben F18 injection), expanding its indication for selecting patients for amyloid-targeting therapies, as described in the prescribing information of the therapeutic products, and including the utilisation of quantitative analysis for positron emission tomography (PET) scans.

Key updates to the Neuraceq label include: expanded clinical indication to include use in both diagnostic assessment and identification of appropriate candidates for FDA-approved amyloid-targeting therapies; utilisation of quantitative amyloid plaque metrics in conjunction with visual image interpretation; and broader use for monitoring of therapy and following progression to Alzheimer's disease (AD).

The safety profile of Neuraceq has been confirmed to remain unchanged with the new indication.

Neuraceq is indicated for PET of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for evaluation of AD and other causes of cognitive decline, and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.