BEDFORD, Mass. — Lantheus Holdings, Inc. said the U.S. Food and Drug Administration has approved TAUKLARIFY (florquinitau F 18 injection), a PET imaging agent for adults with cognitive impairment who are being evaluated for Alzheimer’s disease.
TAUKLARIFY, also previously referred to as MK-6240, is a radiodiagnostic agent indicated for positron emission tomography, or PET, imaging of the brain to identify patients with tau neurofibrillary tangle pathology.
“Today’s approval of TAUKLARIFY reflects both the increasing importance of tau imaging in Alzheimer’s disease assessment and the innovative development program that supported this milestone,” said Mary Anne Heino, Executive Chairperson and CEO of Lantheus. “As the field continues to advance, clinicians are seeking a more complete understanding of this disease, with tau PET imaging providing information that complements amyloid PET and other diagnostic tools.”
In 2023, Enigma Biomedical USA sold its subsidiary Cerveau Technologies to Lantheus, which acquired MK-6240 and took responsibility for completing its development and commercialization. Enigma and Lantheus continued to collaborate on the product following the acquisition.
Samantha Budd Haeberlein, Ph.D., Chief Medical Officer of Enigma Biomedical USA, said the imaging agent could provide additional information about Alzheimer’s disease across different stages of cognitive impairment.
“TAUKLARIFY imaging will enable improved understanding of the status of Alzheimer’s disease patients across the spectrum of cognitive impairment, including those in the early stages of the disease,” Haeberlein said. “Two large, independent clinical studies demonstrated the efficacy and safety of TAUKLARIFY in assessing the status of NFTs in patients being evaluated for Alzheimer’s disease.”
The FDA approval was supported by two blinded-read studies that analyzed TAUKLARIFY PET images from more than 500 participants across three clinical trials. The trials included people with mild cognitive impairment, mild Alzheimer’s disease dementia and cognitively unimpaired individuals.
In Study 1, which analyzed images from 279 participants, positive percent agreement across readers ranged from 80% to 88%, while negative percent agreement ranged from 98% to 99%.
In Study 2, which analyzed images from 338 participants, positive percent agreement ranged from 68% to 82%, while negative percent agreement ranged from 93% to 99%.
Inter-reader agreement was high in both studies, with generalized Fleiss’ kappa values of 0.92 in Study 1 and 0.86 in Study 2.
Safety was evaluated in 1,734 participants. The most commonly reported adverse reactions included headache, nausea, injection-site reactions, dizziness and abdominal discomfort.
“For clinicians and researchers, tau PET imaging is an important tool for identifying tau pathology in the brain and advancing our understanding of Alzheimer’s disease,” said Keith Johnson, Professor of Neurology and Radiology at Massachusetts General Hospital and Harvard Medical School. “The use of sensitive quantitative tau PET imaging is essential for increasing our understanding of potential disease impacts and moving novel treatments forward.”
TAUKLARIFY is approved for PET imaging of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify tau neurofibrillary tangle pathology.
The product carries a limitation of use stating that its safety and effectiveness have not been established for evaluating non-Alzheimer’s disease tauopathies.
The prescribing information also notes that a negative TAUKLARIFY scan does not necessarily exclude the presence of tau pathology, while a positive scan does not necessarily confirm the presence of tau pathology. Additional evaluation should be considered when clinical uncertainty remains.
Because TAUKLARIFY is radioactive, it contributes to a patient’s cumulative radiation exposure. The prescribing information advises safe handling and recommends that patients hydrate before and after administration and urinate frequently afterward.
Lantheus said it plans to continue supporting Alzheimer’s disease therapeutic programs through its Pharma Solutions business while assessing the appropriate path toward broader commercial availability of TAUKLARIFY.
