Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ:LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced U.S. Food and Drug Administration (FDA) approval of TAUKLARIFY™ (florquinitau F 18 injection), also referred to as MK-6240, a radiodiagnostic agent indicated for positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle (NFT) pathology. TAUKLARIFY has a limitation of use. The safety and effectiveness of TAUKLARIFY have not been established for the evaluation of non-Alzheimer's disease tauopathies.
Following approval, Lantheus intends to continue supporting Alzheimer’s disease therapeutic programs through its Pharma Solutions business while assessing the appropriate path toward broader commercial availability. Lantheus’ approach will remain aligned with the needs of its partners and informed by developments across the Alzheimer’s disease treatment landscape.
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