The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Iqirvo (elafibranor) to treat a rare type of liver disease known as primary biliary cholangitis (PBC).

Developed by the French biopharmaceutical company Ipsen, Iqirvo is an oral, peroxisome proliferator-activated receptor (PPAR) agonist.

It helps improve liver function by reducing the amount of bile acids the liver produces and the build-up of bile, along with reducing inflammation of the liver.

The British health regulator recommends a dose of one Iqirvo tablet daily for adult patients, taken at the same time each day.

It can be used as a standalone treatment or in combination with ursodeoxycholic acid (UDCA).

The UK approval of Iqirvo follows the US Food and Drug Administration’s (FDA) approval, and the European Commission’s (EC) approval, in the same indication.

MHRA healthcare quality and access interim executive director Julian Beach 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 approval of Iqirvo was based on a placebo-controlled study of 161 adults with PBC, most of whom had been on UDCA for at least a year and continuing during the study.

In the study, the effectiveness of the Iqirvo tablet was measured based on the number of patients whose blood levels of Alkaline Phosphatase (ALP) and bilirubin decreased to normal levels.

The study showed that the drug was more effective than a placebo in reducing the blood levels of ALP and bilirubin.

After one year, 51% of patients treated with elafibranor met the target reduction in ALP and bilirubin, compared to only 4% in the placebo group.