The US Food and Drug Administration approved florquinitau F 18 injection (TAUKLARIFY), a radiodiagnostic agent indicated for brain positron emission tomography in adults with cognitive impairment undergoing evaluation for Alzheimer’s disease, according to Lantheus Holdings.
The approval was supported by two blinded read studies that evaluated TAUKLARIFY positron emission tomography (PET) images from more than 500 participants across three clinical trials. The trials included participants with mild cognitive impairment or mild Alzheimer’s disease dementia and cognitively unimpaired participants. All participants received an intravenous dose of approximately 185 MBq of TAUKLARIFY for tau PET imaging.
In both studies, independent readers trained in image interpretation assessed scans while blinded to participants’ clinical information and amyloid beta PET results. Readers classified scans as positive or negative for tau neurofibrillary tangle pathology and compared them with a reference standard established in advance based on cognitive status and amyloid beta PET findings.
Study 1 evaluated images from 279 participants. Positive percent agreement across readers ranged from 80% to 88%, while negative percent agreement ranged from 98% to 99%. Study 2 evaluated images from 338 participants, with positive percent agreement ranging from 68% to 82% and negative percent agreement ranging from 93% to 99%. Inter-reader agreement was high in both studies.
Safety was assessed in 1,734 participants. Headache was reported in 0.7%, nausea in 0.2%, and injection-site reactions, dizziness, and abdominal discomfort in 0.1% each.
According to the press release, TAUKLARIFY may perform less well in identifying tau neurofibrillary tangle pathology in participants at earlier stages of the pathological spectrum. A negative scan does not necessarily exclude tau neurofibrillary tangle pathology; positive and negative scan results should be interpreted in the context of the full clinical evaluation.
TAUKLARIFY contributes to cumulative radiation exposure over time, which is associated with a higher risk of cancer. Its safety and effectiveness have not been established for evaluating non-Alzheimer’s disease tauopathies.
Source: Lantheus Holdings
