On November 27, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for flortaucipir (Tauvid), a radiopharmaceutical formulation, intended for adults experiencing memory concerns. This enables doctors to conduct PET (Positron Emission Tomography) brain scans.
Utilized in conjunction with other cognitive assessments and neurological exams, flortaucipir can assist physicians in pinpointing potential causes of memory issues by revealing abnormal tau protein accumulation in the brain.
In patients with Alzheimer’s disease, abnormal tau protein aggregates can be detected using this method, assisting in the disorder’s diagnostic process.
Julian Beach, MHRA Interim Executive Director for Healthcare Quality and Access, emphasized the focus on ensuring UK patients receive secure and efficient treatments: “We are committed to maintaining the highest regulatory standards in granting medicinal approvals. “We continuously monitor product safety post-approval.”
Administered intravenously approximately 80 minutes prior to PET imaging, flortaucipir should be assessed alongside clinical evaluations and additional diagnostics, as PET scans alone cannot conclusively diagnose Alzheimer’s disease in affected individuals.
This decision is validated by findings from a diagnostic performance investigation, where the PET scans identified 92% of individuals with significant tau protein deposition as positive, establishing a sensitivity rate of 92%. Meanwhile, 76% of those without notable tau protein buildup were correctly deemed negative, resulting in a specificity rate of 76%.
A different study assessed flortaucipir’s performance, showing a PET scan sensitivity of 89% and specificity of 77%. This highlighted an 89% accuracy rate in identifying patients with substantial plaques, and a 77% rate in confirming the absence of significant plaques.
A comprehensive list of potential side effects related to this medication can be found in the patient leaflet or through product information on the MHRA website.
The MHRA will continue to rigorously evaluate the safety and efficacy of flortaucipir over time.
Individuals suspecting adverse effects are urged to consult healthcare professionals and report concerns via the Yellow Card scheme, accessible online or via the MHRA Yellow Card app available in app stores.
The marketing approval for flortaucipir (Tauvid) was conferred on the same date to Eli Lilly Nederland B.V. via a national procedure.
The MHRA diligently regulates all medications and medical devices within the UK, ensuring their efficacy and safety are grounded in solid, evidence-based assessments, balancing benefits against any potential risks.