Lantheus, which recently agreed to an $8 billion takeover by fellow radiopharma Curium, garnered FDA clearance for its Alzheimer’s PET imaging agent, Tauklarify.
The clearance for the imaging agent, which also goes by MK-6240, is only for use in patients with cognitive impairment who are being evaluated for the disease to identify tau neurofibrillary tangle pathology, the company said.
The imaging agent cannot be used for non-Alzheimer’s disease tauopathies.
“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,” Mary Anne Heino, executive chair and CEO of Lantheus, said in a statement. “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.”
The approval was supported by two separate clinical trials of more than 500 participants with either mild cognitive impairment, mild Alzheimer's disease dementia, or those who were deemed cognitively unimpaired.
“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,” Keith Johnson, professor of Neurology and Radiology at the Harvard Medical School and Massachusetts General Hospital, added in a release. “The use of sensitive quantitative tau PET imaging is essential for increasing our understanding of potential disease impacts and moving novel treatments forward.”
The regulatory approval comes quickly on the heels of news that Curium would acquire Lantheus in an $8 billion deal expected to close in the first half of next year.
Under terms of the deal, which had been the subject of speculation for several months, Curium will buy all outstanding Lantheus shares for $102.50 each. Another $12 per share would go to shareholders based on value rights linked to sales milestones for Lantheus’ prostate cancer, neurology and Definity franchises through 2030.