Lantheus Holdings has received U.S. Food and Drug Administration (FDA) approval for Tauklarify (florquinitau F-18 injection), a radiodiagnostic agent for tau PET imaging of the brain in adults with cognitive impairment being evaluated for Alzheimer's disease.
The tracer, previously known as MK-6240, is designed to target aggregated tau protein in the form of tau neurofibrillary tangles (NFTs), a hallmark of several neurodegenerative diseases, including Alzheimer’s disease, according to the company. It had previously been granted fast-track status by the FDA.
Lantheus acquired the rights to MK-6240 from Enigma Biomedical (EB) USA in 2023 and continued to collaborate with EB USA on the PET tracer's development.
Approval was supported by two blinded read studies analyzing PET images from more than 500 subjects across three clinical trials, with positive percent agreement ranging from 68% to 88% and negative percent agreement ranging from 93% to 99% across readers, according to the vendor.
Tauklarify's safety and effectiveness have not been established for evaluating non-Alzheimer's disease tauopathies, the firm noted. Lantheus said it plans to continue supporting Alzheimer's disease research through its Pharma Solutions business while assessing the path toward broader commercial availability.
