Aug 14 (Reuters) – The U.S. Food and Drug Administration has approved a radioactive agent from Lantheus Holdings for use in brain scans to help assess patients for Alzheimer’s disease, the company said on Friday.
The agent, branded as Tauklarify, is injected before a positron emission tomography, or PET, scan. It makes abnormal deposits of tau proteins linked to Alzheimer’s visible in images of the brain in adults with cognitive impairment who are being assessed for the disease.
A positive scan does not necessarily confirm tau pathology, while a negative scan does not rule it out, the company said.
The approval was supported by two studies in which independent readers assessed Tauklarify PET scans from more than 500 participants and classified them as positive or negative for tau pathology.
(Reporting by Kunal Das and Puyaan Singh in Bengaluru; Editing by Devika Syamnath)
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