USFDA greenlights label update for Eli Lilly Amyvid to support Alzheimer's disease diagnosis in patients
Indianapolis: Eli Lilly and Company has recieved approval from the U.S. Food and Drug Administration (U.S. FDA) for a label update for Amyvid (florbetapir F 18 injection) for intravenous use.
Amyvid is used for brain imaging to estimate amyloid plaque density in patients with cognitive impairment being evaluated for Alzheimer’s disease and other causes of cognitive decline.
The label update includes the following:
- Revises how Amyvid can be used to estimate plaque density in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline and in patients who are potential candidates for amyloid-targeting therapy.
- Provides a new indication for the selection of patients for amyloid-targeting therapy.
- Quantification of amyloid plaque levels can be used in conjunction with the visual interpretation.
- Updates the clinical studies section of the label to note that amyloid beta positron emission tomography (PET) scans have been used to assess reduction of plaque in some clinical trials of amyloid-targeting therapies as also described in the prescribing information of the therapeutic products.
Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease – and is the target of approved medicines. Amyvid binds to amyloid plaques, which can be detected using positron emission tomography (PET) scan images of the brain and can help confirm or identify presence of excessive amyloid plaque levels to aid in the diagnosis of Alzheimer’s disease when paired with other diagnostic evaluations.
“Nearly 80% of Americans would prefer to know if they have an Alzheimer’s diagnosis before their memory and thinking symptoms disrupt daily life3, highlighting the importance of advanced diagnostic tools like amyloid PET and blood biomarker testing,” said Mark Mintun, M.D., group vice president, Neuroscience Research & Development, Lilly. “The modernization 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.”
In patients being evaluated for Alzheimer’s disease and other cognitive issues who haven’t been treated with an amyloid-targeting therapy:
- A negative scan means there are few or no amyloid plaques, making Alzheimer’s disease less likely.
- A positive scan shows moderate to frequent amyloid plaques, indicating a higher chance of Alzheimer’s disease.
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