Enigma Biomedical USA Announces FDA Approval of TAUKLARIFY™ (florquinitau F 18 injection) for Use in Patients Being Evaluated for Alzheimer’s Disease
A novel diagnostic agent to identify patients with tau neurofibrillary tangles (NFTs), including NFTs isolated to the medial temporal lobe
Enigma Biomedical USA (EB USA) today announced the U.S. Food and Drug Administration (FDA) approval of TAUKLARIFY™ (florquinitau F 18 injection, also previously 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.
In 2023, EB USA sold its subsidiary, Cerveau Technologies, to Lantheus to complete development of and commercialization of TAUKLARIFY. The companies have continued to collaborate to advance product development, which has culminated in this FDA Approval.
Rick Hiatt, President and CEO of EB USA stated: “The FDA granted Fast Track designation to TAUKLARIFY, a status to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. With the approval of TAUKLARIFY, EB USA demonstrates its ongoing commitment to be the premier developer of imaging biomarkers for neurological pathologies to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases.”
