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Amyvid (FLORBETAPIR F 18)
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 name | FLORBETAPIR F 18 |
|---|---|
| Sponsor | Avid Radiopharms Inc |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Target | Amyloid beta A4 protein |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2012 |
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
- Positron emission tomography
Common side effects
- Headache
- Musculoskeletal pain
- Blood pressure increased
- Nausea
- Fatigue
- Injection site reaction
- Anxiety
- Back pain
- Claustrophobia
- Dizziness
- Feeling cold
- Insomnia
Key clinical trials
- Alzheimer's Disease Neuroimaging Initiative 4
- Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis (PHASE1,PHASE2)
- Biomarker Exploration in Aging, Cognition and Neurodegeneration (PHASE3)
- Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography (PHASE4)
- A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)
- Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau (PHASE1)
- Effects of Brain Beta-Amyloid on Postoperative Cognition (PHASE4)
- Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07 (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |