FDA signs off on GE Healthcare's Alzheimer's imaging agent

GE Healthcare ($GE) has gained FDA approval for an imaging agent designed to help evaluate patients for Alzheimer's disease or dementia. Regulators announced the approval, which designates flutemetamol--now called Vizamyl--as a "radioactive diagnostic drug" for use in PET imaging of the brain in adults being scrutinized for either condition. Patents are injected with the agent before PET scans designed to detect beta amyloid deposits in the brain, which are widely believed to be red flags for Alzheimer's development. Vizamyl attaches to the beta amyloid. Last year, GE licensed the agent to Merck ($MRK) for use on select trial participants for MK-8931, Merck's hoped-for Alzheimer's blockbuster drug. FDA notice | GE release | FierceDiagnostics' take

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.