The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved flortaucipir (Tauvid), a diagnostic imaging agent developed by Eli Lilly Nederland.
Tauvid is now approved for British adult patients showing signs of cognitive impairment for Alzheimer’s disease (AD).
The radiopharmaceutical is used for PET (Positron Emission Tomography) brain scans in adults with memory problems.
It helps estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for AD.
Flortaucipir, combined with other brain function tests, helps doctors identify the cause of memory problems by detecting abnormal forms of tau protein in the brain. Abnormal tau is a key AD marker, making PET scans with flortaucipir useful in diagnosing the condition.
The US Food and Drug Administration (FDA) approved the agent in May 2020.
MHRA healthcare quality and access interim executive director Julian Beach said: “We are focused on providing UK patients access to safe and effective medicines.
“We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”
Flortaucipir is injected into a vein about 80 minutes before obtaining an image from a PET scan. Doctors use the scan results alongside clinical evaluation and other diagnostic tools.
MHRA said a Tauvid PET scan alone cannot confirm or rule out an Alzheimer’s diagnosis in patients with cognitive impairment.
This approval is based on the results from a diagnostic performance study that showed that Flortaucipir PET scans demonstrated a sensitivity of 92% in the ability to detect significant buildup of abnormal tau protein in the brain.
Additionally, 76% of patients without significant tau buildup were correctly identified as negative, showing a specificity of 76%. Tau protein buildup refers to abnormal protein clusters that accumulate between nerve cells.
A separate study evaluated the diagnostic performance of Tauvid PET scans in patient with significant plaque buildup. The PET scans showed a sensitivity of 89% and specificity of 77%.
Tauvid was developed by Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company. Avid has also developed Amyvid (Florbetapir F 18 Injection).
In a similar development, in September, GE HealthCare secured FDA approval for Flyrcado (flurpiridaz F 18) injection, a PET radiotracer to diagnose coronary artery disease (CAD).
