FDA Approves New Tau PET Imaging Agent for Alzheimer’s Disease

The Food and Drug Administration (FDA) has approved the tau positron emission tomography (PET) imaging agent florquinitau F 18 injection (Tauklarify, Lantheus) for identifying tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease.

In two recent blinded studies, use of the florquinitau F 18 injection demonstrated overall inter-reader agreement ranging between 86 to 92 percent. For positive cases with florquinitau F 18 injection, researchers noted agreement ranging from 68 to 88 percent. For ruling out identifying tau neurofibrillary tangle pathology, use of florquinitau F 18 injection facilitated agreement across readers ranging from 93 to 99 percent, according to Lantheus.

The company also noted the safety profile of florquinitau F 18 injection. In a study involving 1,734 people who had florquinitau F 18 injection, Lantheus pointed out that the three most common adverse reactions were headache (0.7 percent), nausea (0.2 percent) and injection site reaction (0.1 percent).

“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, MD, a professor of neurology and radiology at Harvard Medical School and Massachusetts General Hospital. “The use of sensitive quantitative tau PET imaging is essential for increasing our understanding of potential disease impacts and moving novel treatments forward.”