FDA Approves Tauklarify Tau PET Scan for Alzheimer Disease Evaluation
KEY TAKEAWAYS
- Tauklarify is now FDA approved for tau PET imaging in adults with cognitive impairment being evaluated for Alzheimer disease.
- In 2 studies totaling 617 individuals, readers achieved 68% to 88% positive agreement and 93% to 99% negative agreement with the study reference standard.
- Tauklarify identifies tau neurofibrillary tangle pathology, but a positive or negative scan does not independently confirm or exclude tau pathology.
The Food and Drug Administration (FDA) has approved Tauklarify (florquinitau F 18 injection; Cerveau Technologies, a Lantheus company) for PET imaging of the brain in adults with cognitive impairment who are being evaluated for Alzheimer disease (AD). The radiodiagnostic agent is indicated to identify patients with tau neurofibrillary tangle (NFT) pathology.
The approval was supported by 2 clinical studies that included scans from 617 individuals: 152 with mild AD dementia, 157 with mild cognitive impairment, and 308 who were cognitively unimpaired. Five independent blinded readers in each study classified scans as positive or negative for tau NFT pathology. Results were compared with a prespecified reference standard based on cognitive status and amyloid beta PET pathology status.
What the Data Showed
- In Study 1 (n=279), positive percent agreement (PPA) ranged from 80% to 88% across readers, while negative percent agreement (NPA) ranged from 98% to 99%.
- In Study 2 (n=338), PPA ranged from 68% to 82%, and NPA ranged from 93% to 99%.
- Inter-reader agreement was high, with generalized Fleiss κ values of 0.92 in Study 1 and 0.86 in Study 2.
- Among 1734 individuals evaluated for safety, headache was the most frequently reported adverse reaction (0.7%).
The prescribing information cautions that Tauklarify performance for identifying tau NFT pathology may be lower in patients at earlier stages of the pathologic spectrum. A negative scan does not necessarily exclude tau NFT pathology, and a positive scan does not necessarily indicate histopathologically confirmed tau NFT pathology. The safety and effectiveness of Tauklarify have not been established for evaluating non-AD tauopathies.
Source
Enigma Biomedical USA. Enigma Biomedical USA Announces FDA Approval of TAUKLARIFY™ (florquinitau F 18 injection) for Use in Patients Being Evaluated for Alzheimer’s Disease. Press release. August 14, 2026. https://www.businesswire.com/news/home/20260814732640/en/Enigma-Biomedical-USA-Announces-FDA-Approval-of-TAUKLARIFY-florquinitau-F-18-injection-for-Use-in-Patients-Being-Evaluated-for-Alzheimers-Disease