Date: 2012-10-21
Type of information:
Product name: Amyvid®
Compound: florbetapir 18F
Therapeutic area:
Action mechanism: Amyvid® is a radioactive diagnostic agent, tagged with a radioisotope called fluorine-18. Once Amyvid® is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques. Amyvid® produces a positron signal, which is detected by a PET scanner and used to create a brain image. A physician who should have successfully completed Amyvid® reader training then interprets the image to evaluate as positive or negative for significant levels of amyloid plaques (i.e., moderate to frequent levels of neuritic plaques) in the brain. This information is reported back to the referring physician, who then determines the next steps in the evaluation and management of the patient.
Company: Eli Lilly (USA)
Disease: Radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of Beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment
Latest news: * On September 27, 2013, Eli Lilly has announced that the Centers for Medicare & Medicaid Services (CMS) has denied patient access to beta-amyloid imaging agents, such as Amyvid™ (Florbetapir F 18 Injection). The company stated that "this final decision is not only contrary to expert opinion and published Appropriate Use Criteria previously recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging, but contradicts the statutory authority CMS has over coverage determinations for diagnostics. Denying appropriate patient access is also in conflict with the administration's National Alzheimer's Project Act. CMS participated in creating this plan aimed at developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer's Disease—yet the same agency is challenging the value of the only technology approved by the FDA for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis."
* On January 16, 2013, Eli Lilly and Avid Radiopharmaceuticals, announced the European Commission has approved Amyvid® (Florbetapir (18F)) solution for injection as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. Amyvid® should be used in conjunction with a clinical evaluation.
Initially, Amyvid® will be available in select areas within the European Union (EU) beginning in the second quarter of 2013.
The approval of Amyvid® was based on data submitted by Lilly, including several trials supporting the safety, technical and diagnostic performance of Amyvid. In the pivotal study involving end of life patients, the diagnostic performance of Amyvid® to detect the cortical neuritic plaque density (no or sparse versus moderate or frequent) was evaluated in 59 subjects who underwent an Amyvid® PET scan and then had neuropathological evaluation of beta-amyloid deposition in the brain after death. In the 59 subjects, a blinded PET reading by five nuclear medicine physicians resulted in a majority read sensitivity of 92 percent (95 percent CI: 78 - 98 percent) and specificity of 100 percent (95 percent CI: 80 - 100 percent). Sensitivity is the ability to appropriately detect moderate or frequent plaques and specificity is the ability to appropriately detect sparse or no plaques. In a study of 47 young ( < 40 years), healthy volunteers, presumed to be free of beta-amyloid, all Amyvid PET scans were negative.
Adverse reactions have been collected in clinical studies involving 555 subjects and 665 administrations of Amyvid ®solution for injection. No serious adverse reactions related to Amyvid® administration have been reported. The only adverse reaction considered to be common (defined as > =1/100 to < 1/10) is headache. Uncommon (defined as > =1/1,000 to < 1/100) adverse reactions reported included dysgeusia, flushing, nausea, pruritis, urticarial and infusion site rash.
* On October 19, 2012, Eli Lilly and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced they received a positive opinion from the CHMP in Europe, recommending approval of Amyvid® (Florbetapir F 18) solution for injection as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive impairment. Amyvid® should be used in conjunction with a clinical evaluation.
A negative Amyvid® scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's Disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease.
A positive Amyvid® scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.
It's important to note that Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.
* On April 10, 2012, the FDA approved Amyvid® for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. Amyvid is used to produce PET scans that estimate the brain Bêta-amyloid neuritic plaque density in patients with cognitive impairment.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-04-10
UE authorization: 2013-01-16
Favourable opinion UE: 2012-10-18
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
