Published 8 October 2024
Last updated 15 October 2024 — See all updates
PBC is a type of chronic liver disease in which the small bile
ducts in the liver become injured and inflamed and are eventually
destroyed. Where there are damaged bile ducts, bile builds up and
causes liver damage. This disease can get gradually worse over
time and without treatment may lead to liver failure.
Elafibranor helps to improve how the liver works by reducing the
amount of bile acids the liver produces and reducing the build-up
of bile. It also acts by reducing inflammation of the liver.
The recommended dose is one tablet, once a day, at about the same
time each day for adult patients. Elafibranor may be given by
itself or together with ursodeoxycholic acid (UDCA).
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
Enabling safe access to high quality, safe and effective
medicines is a key priority for us.
We're assured that the appropriate regulatory standards of
safety, quality and effectiveness for the approval of this new
formulation have been met.
As with all products, we will keep its safety under close
review.
The MHRA's approval of the medicine is supported by evidence from
a placebo-controlled main study involving 161 adults with PBC,
the majority of whom had been taking UDCA for at least one year
and continued taking it during the study (though some had stopped
taking due to side effects).
The measure of effectiveness was based on the number of patients
whose blood levels of the substances Alkaline Phosphatase (ALP)
and bilirubin (markers of liver damage) decreased to a level
considered normal (for both ALP and bilirubin) and by at least
15% (for ALP) after 1 year of treatment.
The study showed that elafibranor was more effective than placebo
at reducing the blood levels of ALP and bilirubin. Overall,
levels decreased by the required amount in around 51% (55 out of
108) of patients treated with elafibranor, compared with around
4% (2 out of 53) of patients on placebo.
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.
If a patient experiences any side effects, they should talk to
their doctor, pharmacist, or nurse. This includes any possible
side effects not listed in the product information leaflets.
Anyone who suspects they are having a side effect from this
medicine is encouraged to talk to their doctor, pharmacist or
nurse and report it directly to the MHRA's Yellow Card scheme.
ENDS
Notes to editors
- The new marketing authorisation was granted for elafibranor
(Iqirvo) on 04 October 2024 to Ipsen Ltd 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.
