The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 27 November 2024, approved the medicine flortaucipir
(Tauvid), a radiopharmaceutical product given to adults with
memory problems so that doctors can perform a type of brain scan
called a PET (Positron Emission Tomography) scan.
Along with other brain function tests, flortaucipir may help the
patient's doctor find the reason for their patient's memory
problems by helping to determine whether they have abnormal forms
of tau protein in their brain.
Abnormal forms of tau protein are present in the brain of people
with Alzheimer's disease, and therefore PET scans using this
product can assist in the diagnosis of the condition.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access, 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 given by injection into a vein about 80 minutes
before obtaining an image from a PET scan.
Doctors will need to use the scans together with clinical
evaluation and other diagnostic tools. Flortaucipir PET scan
results on their own cannot confirm or refute a diagnosis of
Alzheimer's disease in patients with cognitive impairment.
This approval is supported by evidence from a diagnostic
performance study, in which it was shown that PET scans
identified 92% of the patients who had significant buildup of tau
protein (which are abnormal clusters of protein fragments that
build up between nerve cells) as positive. This meant that
Flortaucipir PET scan had a sensitivity of 92% in the ability to
detect significant buildup of abnormal tau protein in the
brain. 76% of patients without significant tau protein
buildup were correctly rated as negative, i.e., Flortaucpir PET
had a specificity (the ability to correctly identify absence of
the disease) of 76%.
A separate study evaluated diagnostic performance of
flortaucipir, and the PET scans in this study were shown to have
a sensitivity of 89% and a specificity of 77%. This meant that
the PET scans were able to correctly identify as positive 89% of
the patients who had significant amounts of plaques, and that 77%
of patients without significant plaques were correctly rated as
negative.
A full list of all side effects reported with this medicine is
available in the patient information leaflet or from the product
information published on the MHRA website.
As with any medicine, the MHRA will keep the safety and
effectiveness of flortaucipir under close review.
Anyone who suspects they are having a side effect from this
medicine are encouraged to talk to their doctor, pharmacist or
nurse and report it directly to the Yellow Card scheme, either
through the website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
ENDS
Notes to editors
- The new marketing authorisation was granted for flortaucipir
(Tauvid), on 27 November 2024 to Eli Lilly Nederland B.V. via
national procedure.
- More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will be
published on the MHRA Products
website within 7 days of approval.
