Medicines Healthcare Products Regulatory Agency
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).
Julian 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.
Were 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 MHRAs 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 MHRAs 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.
- The MHRA is an executive agency of the Department of Health and Social Care.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or cal