Eli Lilly’s Tauvid (flortaucipir F 18) Receives the US FDA’s Approval as the First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease

Eli Lilly and Incyte’s OLUMIANT (baricitinib) Receives the US FDA’s Breakthrough Therapy Designation for Alopecia Areata

Shots:

The safety and effectiveness of Tauvid imaging is evaluated in two clinical studies. In study 1, reader interpretations of premortem TAUVID scans from 64 cognitively normal & terminally ill patients agreed to undergo Tauvid imaging and participate in a post-mortem brain donation program were compared to tau pathology at autopsy. The study met its 1EPs as with reader sensitivity ranging from 92%-100% & specificity from 52%- 92%
In study 2, images from the same terminally ill patients as in Study 1 and 159 patients with cognitive impairment being evaluated for AD were evaluated by 5 new readers. The study met criteria for comparison of Tauvid reads to NFT pathology, additionally, inter-reader agreement was evaluated using Fleiss’ kappa statistic and found to be 0.87 across 241 patients in Study 2
The availability of Tauvid will initially be limited and will expand in response to commercial demand and payor reimbursement. Tauvid is the first and only approved diagnostic agent to image tau NFTs in the brain