FDA Approves Lantheus Tau PET Imaging Agent for Alzheimer’s

The U.S. Food and Drug Administration (FDA) has approved Lantheus Holdings’ TAUKLARIFY (florquinitau F 18 injection), a radiodiagnostic agent designed to help identify tau pathology in the brains of adults being evaluated for Alzheimer’s disease.

TAUKLARIFY, also known as MK-6240, is used with positron emission tomography (PET) brain imaging in adults with cognitive impairment. The imaging agent helps clinicians identify tau neurofibrillary tangles, a key feature associated with Alzheimer’s disease.

The approval gives clinicians another tool to assess Alzheimer’s disease and understand changes in the brain. Tau PET imaging can provide information that complements amyloid PET scans and other diagnostic methods used in the evaluation of the disease.

“Today’s approval of TAUKLARIFY reflects both the increasing importance of tau imaging in Alzheimer’s disease assessment,” said Mary Anne Heino, Executive Chairperson and CEO of Lantheus. She added that the company remains focused on supporting research into the role of tau imaging in understanding Alzheimer’s disease.

TAUKLARIFY’s approval was supported by two blinded image-read studies involving more than 500 people who took part in three clinical trials. The studies included people with mild cognitive impairment, mild Alzheimer’s disease dementia and people without cognitive impairment. This allowed researchers to assess the imaging agent across different stages of cognitive health.

Participants received an approximate intravenous dose of 185 MBq (5 mCi) of TAUKLARIFY for the tau PET scans. Independent readers who were trained to interpret the images and were unaware of the participants’ clinical information and amyloid PET results then reviewed the scans.

In the first study, researchers analyzed images from 279 participants. Positive agreement between readers ranged from 80% to 88%, while negative agreement ranged from 98% to 99%. The study also showed high agreement between the independent readers.

The second study included images from 338 participants. Positive agreement ranged from 68% to 82%, while negative agreement ranged from 93% to 99%. Reader agreement was also high in this study.

The safety profile of TAUKLARIFY was evaluated in 1,734 subjects. The most commonly reported adverse reactions were headache, nausea, injection site reactions, dizziness and abdominal discomfort. Headache was reported in 0.7% of subjects, while the other reported reactions occurred in 0.2% or fewer of subjects.

Lantheus said it plans to continue supporting Alzheimer’s disease therapeutic programs through its Pharma Solutions business following the FDA approval. The company is also evaluating the appropriate approach for broader commercial availability of TAUKLARIFY.

The company said its plans will take into account the needs of its partners and changes in the Alzheimer’s disease treatment landscape.

Tau is a protein that can form abnormal tangles inside brain cells in Alzheimer’s disease. Tau PET imaging provides a way to visualize these changes in the brain and may help researchers and clinicians better understand disease progression and evaluate potential treatments.

Keith Johnson, Professor of Neurology and Radiology at Massachusetts General Hospital and Harvard Medical School, said sensitive quantitative tau PET imaging is an important tool for identifying tau pathology and supporting research into new Alzheimer’s treatments.

The FDA approval comes as research into Alzheimer’s disease diagnosis and treatment increasingly focuses on both amyloid and tau pathology. Lantheus said TAUKLARIFY is intended to support the identification of tau neurofibrillary tangle pathology in patients being evaluated for Alzheimer’s disease.

However, the safety and effectiveness of TAUKLARIFY have not been established for evaluating tauopathies that are not related to Alzheimer’s disease.