GE Healthcare's Vizamyl garners FDA approval to help evaluate Alzheimer's disease, dementia
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By: Katie Bell
Ref: FinanzNachrichten, MSN, Centre Daily Times, FDA
Published: 10/25/2013
The FDA said on Friday that it approved GE Healthcare's Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) brain imaging in adults being evaluated for Alzheimer's disease and dementia. The product is the second available for visualising beta amyloid on a PET scan of the brain after the agency cleared Eli Lilly's Amyvid (florbetapir F 18 injection) last year to help evaluate adults for Alzheimer's disease and other causes of cognitive decline.
The regulator noted that since Vizamyl attaches to beta amyloid, a negative Vizamyl PET scan indicates that there is little or no beta amyloid accumulation in the brain and the cause of the dementia is probably not due to Alzheimer's disease. Although a positive scan indicates that there is probably a moderate or greater amount of beta amyloid in the brain, the FDA indicated that "Vizamyl does not replace other diagnostic tests used in the evaluation of Alzheimer's disease and dementia."
Vizamyl's effectiveness was established in two trials, in which 384 participants with a range of cognitive function were injected with Vizamyl and were scanned, with a portion of scan results confirmed by autopsy. The data demonstrated that Vizamyl correctly detected beta amyloid in the brain and confirmed that the scans are reproducible and can be interpreted accurately by trained readers, the FDA said. The product's safety was established in 761 participants, the agency added.
Last month, the US Centers for Medicare & Medicaid Services ruled against reimbursing beta-amyloid imaging agents, determining that there was insufficient evidence that such radioactive imaging tests are "reasonable and necessary" for diagnosing and helping treat dementia. At the time, Eli Lilly said it was "disappointed" with the decision and would review the final ruling to assess "all available options to ensure patients and physicians can gain access" to Amyvid.
The regulator noted that since Vizamyl attaches to beta amyloid, a negative Vizamyl PET scan indicates that there is little or no beta amyloid accumulation in the brain and the cause of the dementia is probably not due to Alzheimer's disease. Although a positive scan indicates that there is probably a moderate or greater amount of beta amyloid in the brain, the FDA indicated that "Vizamyl does not replace other diagnostic tests used in the evaluation of Alzheimer's disease and dementia."
Vizamyl's effectiveness was established in two trials, in which 384 participants with a range of cognitive function were injected with Vizamyl and were scanned, with a portion of scan results confirmed by autopsy. The data demonstrated that Vizamyl correctly detected beta amyloid in the brain and confirmed that the scans are reproducible and can be interpreted accurately by trained readers, the FDA said. The product's safety was established in 761 participants, the agency added.
Last month, the US Centers for Medicare & Medicaid Services ruled against reimbursing beta-amyloid imaging agents, determining that there was insufficient evidence that such radioactive imaging tests are "reasonable and necessary" for diagnosing and helping treat dementia. At the time, Eli Lilly said it was "disappointed" with the decision and would review the final ruling to assess "all available options to ensure patients and physicians can gain access" to Amyvid.