Enigma Biomedical USA has received FDA approval for TauklariFy, or florquinitau F 18 injection, a radiodiagnostic agent used in brain PET imaging for adults with cognitive impairment being evaluated for Alzheimer’s disease.
TauklariFy is intended to identify tau neurofibrillary tangle pathology, including tangles isolated to the medial temporal lobe. The agent, previously known as MK-6240, is administered intravenously before positron emission tomography imaging of the brain.
The approval gives clinicians another diagnostic tool for evaluating the presence of tau pathology, one of the hallmark changes associated with Alzheimer’s disease. Enigma Biomedical USA said the agent can help identify patients with tau neurofibrillary tangles as part of an overall clinical assessment.
The FDA decision was supported by two blinded image-reading studies that evaluated TauklariFy PET scans from more than 500 participants across three clinical trials. Participants included people with mild cognitive impairment, mild Alzheimer’s disease dementia and cognitively unimpaired individuals.
In one study involving 279 participants, positive percent agreement among image readers ranged from 80% to 88%, while negative percent agreement ranged from 98% to 99%. Safety was assessed in 1,734 individuals who received an approximate intravenous dose of 185 MBq, or 5 mCi, of TauklariFy for tau PET imaging.
The most common adverse reactions, each reported in at least 0.1% of patients, were headache, nausea, injection-site reactions, dizziness and abdominal discomfort. Headache occurred in 0.7% of patients and nausea in 0.2%.
TauklariFy’s label includes limitations. Its safety and effectiveness have not been established for evaluating non-Alzheimer’s disease tauopathies. A negative scan does not necessarily rule out tau neurofibrillary tangle pathology, while a positive scan does not necessarily confirm pathology through tissue examination. Additional evaluation should be considered when clinical uncertainty remains.
Rick Hiatt, president and chief executive officer of Enigma Biomedical USA, said the approval follows FDA Fast Track designation for TauklariFy. He said the therapy’s development was supported by two large independent clinical studies demonstrating efficacy and safety in assessing tau neurofibrillary tangles.
The company said TauklariFy will be available through Cerveau Technologies, a Lantheus company, which will handle reporting of suspected adverse reactions and product-related questions.
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