The US Food and Drug Administration (FDA) has granted approval for a label update to Eli Lilly and Company’s Amyvid (florbetapir F 18 injection) for use intravenously.
The update revises the application of Amyvid in estimating amyloid plaque density, which is crucial for patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.
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Amyvid is available in multidose vials with 500-1900MBq/ml strength.
The new label changes include revised usage guidelines to estimate plaque density, providing a fresh indication for selecting patients eligible for amyloid-targeting therapies.
The update also allows quantification of amyloid plaques alongside visual understanding.
The clinical studies section on the label acknowledges that amyloid beta positron emission tomography (PET) scans have helped assess plaque reduction during trials of certain amyloid-targeting treatments.
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By GlobalDataLilly neuroscience research and development group vice-president Mark Mintun stated: “Nearly 80% of Americans would prefer to know if they have an Alzheimer’s diagnosis before their memory and thinking symptoms disrupt daily life, highlighting the importance of advanced diagnostic tools like amyloid PET and blood biomarker testing.
“The modernisation of Amyvid’s label is a significant step in advancing Alzheimer’s care, enabling physicians to help patients make informed decisions, being evaluated for or to aid in the selection of patients who are indicated for amyloid-targeting therapy.”
Amyvid is a radioactive diagnostic drug used for PET to assess the density of amyloid beta neuritic plaques in adults experiencing cognitive impairment for evaluation of Alzheimer’s.
The National Institute for Health and Care Excellence (NICE) recently decided against recommending Eli Lilly’s Kisunla (donanemab) and Eisai’s Leqembi (lecanemab) Alzheimer’s drugs for NHS use.
