FDA Greenlights TAUKLARIFY™, a New Imaging Agent for Alzheimer's Disease

Lantheus Holdings, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved TAUKLARIFY™ (florquinitau F-18 injection), a novel F-18-labeled PET imaging agent designed to assist in the identification of tau neurofibrillary tangles in the brains of adults undergoing evaluation for Alzheimer’s disease. Labeled as MK-6240, this radiodiagnostic tool is intended for use in patients displaying cognitive impairment and suspected Alzheimer’s pathology.

TAUKLARIFY, however, comes with limitations in its application, as its safety and effectiveness for evaluating non-Alzheimer’s tauopathies have not been verified. "Today’s approval of TAUKLARIFY reflects both the increasing importance of tau imaging in Alzheimer’s disease assessment," stated Mary Anne Heino, Executive Chairperson and CEO of Lantheus.

The approval is founded on data from two pivotal blinded read studies, which included over 500 subjects participating in three clinical trials. These trials encompassed individuals with a spectrum of cognitive functions, including mild cognitive impairment and mild Alzheimer’s disease dementia. Subjects received approximately 185 MBq (5 mCi) of TAUKLARIFY intravenously for PET imaging. In the studies, TAUKLARIFY scans were analyzed by independent readers who were trained and blinded to clinical information, including existing amyloid beta PET results.

Study findings demonstrated high inter-reader agreement. In Study 1, which included 279 subjects, Positive Percent Agreement (PPA) ranged from 80% to 88%, while Negative Percent Agreement (NPA) ranged from 98% to 99%. Study 2 evaluated images from 338 subjects, showing a PPA of 68% to 82%, and an NPA of 93% to 99%. Safety was assessed in 1,734 patients, revealing adverse reactions such as headaches and injection site reactions in fewer than 1% of cases.

TAUKLARIFY's approval marks a significant advancement in Alzheimer’s diagnostics. "Tau PET imaging is an important tool for identifying tau pathology," noted Keith Johnson, Professor of Neurology and Radiology at Massachusetts General Hospital and Harvard Medical School. As Lantheus advances with TAUKLARIFY, the company intends to focus on enhancing accessibility through its Pharma Solutions business, ensuring alignment with its strategic objectives in Alzheimer’s research.

For clinicians and medical researchers, this new FDA-approved tau PET imaging agent offers a significant enhancement in assessing Alzheimer’s pathology, supplementing amyloid PET and other diagnostic methodologies. With an estimated 7 million Americans currently affected by Alzheimer’s and projections of increased prevalence, TAUKLARIFY presents a timely addition to diagnostic arsenals, aimed at fostering early and accurate detection of this progressive neurological disorder.