by John R. Fischer
, Senior Reporter | June 01, 2020
"History was made with the FDA approval of AMYVID to demonstrate the presence of one of those two pathologies, beta-amyloid plaques,” said Dr. Mark Mintun, vice president of Lilly's pain and neurodegeneration research and development, in a statement. “I am excited that TAUVID has now been approved to image tau NFTs, which is the other key pathology, allowing a more comprehensive evaluation of patients."
Approval of Tauvid was granted under Priority Review, in which the FDA takes action on an application within six months and determines that the drug, if approved, significantly improves the safety or effectiveness of treating, diagnosing or preventing a serious condition.
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Tauvid’s ability to detect tau pathology was assessed in patients with generally severe stages of dementia and may be lower in patients in earlier stages of cognitive decline than in the patients with terminal illness who were studied. The most common adverse reactions were headache, injection site pain and increased blood pressure. The drug is not indicated for assessing patients for chronic traumatic encephalopathy (CTE).
Availability of Tauvid will initially be limited, but will expand as commercial demand and payor reimbursement grow. Back to HCB News