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Amyvid (FLORBETAPIR F 18)

Avid Radiopharms Inc · FDA-approved approved Small molecule Quality 48/100

Amyvid works by binding to amyloid beta A4 protein in the brain, allowing for visualization of amyloid plaques in Alzheimer's disease.

Amyvid (Florbetapir F 18) is a radioactive diagnostic agent developed by Avid Radiopharmaceuticals, Inc. It targets the amyloid beta A4 protein, a hallmark of Alzheimer's disease, and is used for positron emission tomography (PET) imaging. Amyvid is a small molecule radioactive agent approved by the FDA in 2012 for its diagnostic indication. It is still patented and has no generic manufacturers. Key safety considerations include radiation exposure and potential allergic reactions.

At a glance

Generic nameFLORBETAPIR F 18
SponsorAvid Radiopharms Inc
Drug classRadioactive Diagnostic Agent [EPC]
TargetAmyloid beta A4 protein
ModalitySmall molecule
Therapeutic areaNeuroscience
PhaseFDA-approved
First approval2012

Mechanism of action

Florbetapir 18 binds to -amyloid plaques and the 18 isotope produces positron signal that is detected by PET scanner. In in vitro binding studies using postmortem human brain homogenates containing -amyloid plaques, the dissociation constant (Kd) for florbetapir was 3.7 +- 0.3 nM. The binding of florbetapir 18 to -amyloid aggregates was demonstrated in postmortem human brain sections using autoradiographic methods, thioflavin and traditional silver staining correlation studies as well as monoclonal antibody -amyloid-specific correlation studies. Florbetapir binding to tau protein and battery of neuroreceptors was not detected in in vitro studies.

Approved indications

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity