On 27 November, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced the approval of flortaucipir, a diagnostic agent for adults with cognitive impairment who are being evaluated for Alzheimer’s disease (AD). This radiopharmaceutical product is used during a type of brain scan called positron-emission tomography (PET) to help detect abnormal forms of the tau protein, a key feature of AD. Developed by Eli Lilly subsidiary Avid Radiopharmaceuticals, flortaucipir received approval from the US Food and Drug Administration (FDA) in 2020 and the European Medicines Agency (EMA) in 2024. Flortaucipir is given by injection into a vein about 80 minutes before obtaining an image from a PET scan. The MHRA approval was based on a diagnostic performance study showing that flortaucipir PET scans had a sensitivity of 92% in the ability to detect significant buildup of abnormal tau protein in the brain. Flortaucipir PET had a specificity of 76% (76% of patients without significant tau protein buildup were correctly rated as negative). MHRA added that flortaucipir PET scan results alone cannot confirm or refute a diagnosis of AD in people with cognitive impairment and that doctors must use the scans alongside other available clinical evaluation and diagnostic tools. Full safety details are available through the MHRA. For more details, you can read the press release: