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鈥檚 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鈥檚 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鈥檚 disease 鈥 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鈥檚 disease when paired with other diagnostic evaluations.鈥淣early 80% of Americans would prefer to know if they have an Alzheimer鈥檚 diagnosis before their memory and thinking symptoms disrupt daily life3, highlighting the importance of advanced diagnostic tools like amyloid PET and blood biomarker testing,鈥 said Mark Mintun, M.D., group vice president, Neuroscience Research & Development, Lilly. 鈥淭he modernization of Amyvid鈥檚 label is a significant step in advancing Alzheimer鈥檚 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.鈥滻n patients being evaluated for Alzheimer鈥檚 disease and other cognitive issues who haven鈥檛 been treated with an amyloid-targeting therapy:A negative scan means there are few or no amyloid plaques, making Alzheimer鈥檚 disease less likely.A positive scan shows moderate to frequent amyloid plaques, indicating a higher chance of Alzheimer鈥檚 disease.Read also: Eli Lilly reports strong response for Mounjaro in India amid rising diabetes, obesity rates