The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Tauvid (flortaucipir), a diagnostic imaging agent developed by Eli Lilly subsidiary Avid Radiopharmaceuticals, to identify whether patients with memory problems may have Alzheimer’s disease.
The agent is designed for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs), a primary marker of Alzheimer’s disease.
Tauvid is given by injection to patients with memory problems about 80 minutes before obtaining an image from a PET scan.
Tauvid received approval from the US Food and Drug Administration (FDA) in 2020.
The MHRA said the approval was based on a performance review study that found that flortaucipir PET scans had a sensitivity of 92% in the ability to detect significant buildup of abnormal tau protein in the brain.
However, the agency stressed that flortaucipir PET scan results alone cannot confirm or refute a diagnosis of Alzheimer’s disease in patients with cognitive impairment and that doctors must use the scans alongside other available clinical evaluation and diagnostic tools.
Julian Beach, interim executive director of healthcare quality and access at the MHRA, 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.’’
Alzheimer’s is the most common form of dementia. Alzheimer’s Disease International (ADI) estimates there were more than 55 million people worldwide living with dementia in 2020 and anticipates this number will almost double every 20 years, reaching 78 million in 2030 and 139 million in 2050.
In related Alzheimer’s diagnostic news, Veravas and Phanes Biotech recently announced a partnership to develop a blood-based tau pathology test for Alzheimer’s disease detection.
In addition, Roche shared new late-breaking data from a prospective trial at the recent 17th Clinical Trials in Alzheimer’s Disease Congress in Madrid, Spain, showing that its Elecsys amyloid plasma panel can rule out Alzheimer’s disease with a high negative predictive value of 96.2%.
