FDA approves Tauvid, first drug to help image certain Alzheimer’s disease signal
The FDA recently announced the approval of Tauvid, an IV injection that is used to help image a specific characteristic of Alzheimer’s disease in the brain known as tau pathology.
Tauvid (flortaucipir F18; Avid Radiopharmaceuticals, Eli Lilly and Co.) is approved for adults who have cognitive impairment and are being evaluated for Alzheimer’s disease, according to an FDA press release. It is a radioactive diagnostic agent that is indicated for positron emission tomography imaging of the brain. The agent is used to assess the density and distribution of aggregated tau neurofibrillary tangles (NFTs), which is a primary signal of Alzheimer’s disease, the release said.
“This approval will provide health care professionals with a new type of brain scan to use in patients being evaluated for Alzheimer’s disease,” Charles Ganley, MD, director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research, said in the release. “While there are FDA-approved imaging drugs for amyloid pathology, this is the first drug approved for imaging tau pathology, one of the two neuropathological hallmarks of Alzheimer’s disease, and represents a major advance for patients with cognitive impairment being evaluated for the condition.”
Previously, estimating the density and distribution of tau NFTs in the brain was only possible during an autopsy, according to a press release from the manufacturer.
“Now we have a way to obtain this important information in patients,” Reisa Sperling, MD, professor of neurology at Harvard Medical School and director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital, said in the release.
The approval was based on findings from two clinical trials. In the first study, researchers enrolled terminally ill patients who agreed to undergo flortaucipir F18 imaging and participate in a postmortem brain donation program. Overall, they evaluated NFTs in 64 patients who died within 9 months of the flortaucipir F18 brain scan. Their readings from the flortaucipir F18 scan were compared with postmortem readings of the same brains from independent pathologists. The results showed that researchers evaluating the flortaucipir F18 brain scans had a high probability of accurately evaluating patients with tau pathology as well as an average to high probability of accurately evaluating patients without tau pathology, according to the FDA release.
In the second study, five new readers assessed scans from the same patients in the first study, plus scans from 18 additional terminally ill patients and 159 patients with cognitive impairment who were being evaluated for Alzheimer’s disease. The study demonstrated reader agreement across all patients, the FDA reported. The agency noted that flortaucipir F18 was able to help detect tau pathology in patients with “generally severe” dementia, but it may be less effective in patients with earlier stages of cognitive decline.
The most common adverse events associated with flortaucipir F18 included headache, injection site pain and increased BP, according to the FDA.
Eli Lilly and Co. Lilly receives U.S. FDA approval of Tauvid (flortaucipir F18 injection) for use in -patients being evaluated for Alzheimer’s disease. https://www.prnewswire.com/news-releases/lilly-receives-us-fda-approval-of-tauvid-flortaucipir-f-18-injection-for-use-in-patients-being-evaluated-for-alzheimers-disease-301067441.html. Accessed May 29, 2020.
FDA. FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-image-tau-pathology-patients-being-evaluated-alzheimers-disease. Accessed May 29, 2020.
Disclosures: Ganley reports no relevant financial disclosures. Healio Primary Care could not confirm Sperling’s relevant financial disclosures at the time of publication.