For patients with cognitive impairment who are being evaluated for Alzheimer’s disease, the U.S. Food and Drug Administration has granted a new label for Eli Lilly and Company’s Amyvid (florbetapir F 18 injectable), which will enhance the diagnostic and therapeutic procedure. The new label provides a new indication for patient selection for amyloid-targeting medicines and modifies the way Amyvid may be used to assess the density of amyloid plaque in the brain.
This important upgrade enables the measurement of the amount of amyloid plaque, which can be combined with a visual reading of the PET scan. This quantitative method is an important step forward in individualizing Alzheimer’s treatment, allowing doctors to make more precise determinations regarding patient management and therapy.
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Amyvid is a radioactive diagnostic tracer that is utilized for Positron Emission Tomography (PET) imaging of the brain. Amyvid binds to amyloid plaques, a feature of Alzheimer’s disease, and thus enables their visualization. The revised label now formally recommends the use of Amyvid in the selection of patients who are appropriate candidates for amyloid-beta-targeted therapies, as specified in the labeling for those treatments.
Nearly 80% of Americans would prefer to know if they have an Alzheimer’s diagnosis before their memory and thinking symptoms disrupt daily life,
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.
Mark Mintun
Amyloid beta PET imaging has been used to quantify plaque reduction in amyloid-targeted treatment clinical trials, according to the label adjustment, which also includes modifications to the section on clinical research. This reaffirms Amyvid’s position in the ever-changing field of Alzheimer’s disease treatment.
The presence of moderate to frequent amyloid plaques is suggested by a positive Amyvid scan, which is consistent with a neuropathological diagnosis of Alzheimer’s disease but can also occur in other neurologic disorders and in older people with normal cognitive function. A negative scan indicates little to no amyloid plaques, making an Alzheimer’s diagnosis less likely.
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In Amyvid’s clinical trials, the most frequent side effects included headache, musculoskeletal pain, high blood pressure, nausea, fatigue, and injection site reactions.
The Alzheimer’s community has benefited greatly from this new name for Amyvid, which offers a more precise diagnostic tool and a more direct route for the implementation of current and upcoming treatments meant to target the underlying pathology of this devastating illness.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
