Iqirvo

Iqirvo received a conditional marketing authorisation valid throughout the EU on 19 September 2024.

Iqirvo is available as tablets to be taken by mouth once a day. The medicine can only be obtained with a prescription.

For more information about using Iqirvo, see the package leaflet or contact your doctor or pharmacist.

The active substance in Iqirvo, elafibranor, works by attaching to and activating cell receptors (targets) called 'PPAR receptors', which are thought to be involved in controlling the levels of bile acid and in the process of liver inflammation and scarring. By activating PPARs, Iqirvo regulates the levels of bile acid. The medicine also has an anti-inflammatory effect on the liver.

Iqirvo was compared with placebo (a dummy treatment) in a main study involving 161 adults with primary biliary cholangitis. The majority of patients had been taking UDCA for at least 1 year and continued taking it during the study but some patients had stopped taking UDCA due to side effects. The measure of effectiveness was based on the number of patients whose blood levels of the substances 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 Iqirvo 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 Iqirvo, compared with around 4% (2 out of 53) of patients on placebo.

For the full list of side effects and restrictions with Iqirvo, see the package leaflet.

The most common side effects with Iqirvo (which may affect more than 1 in 10 people) include abdominal (belly) pain, diarrhoea, nausea (feeling sick) and vomiting. In the clinical study, these side effects were mostly mild to moderate in severity, occurred early during treatment and tended to resolve within days to a few weeks.

Iqirvo must not be used in women who are pregnant, could be pregnant or in women who are able to have children when they do not use contraception.

Patients with primary biliary cholangitis have limited treatment options. Iqirvo has been shown to reduce the blood levels of ALP and bilirubin in patients with primary biliary cholangitis. The extent of the reductions in ALP and bilirubin is considered indicative of an improvement in the condition of the liver. However, as primary biliary cholangitis progresses very slowly, it needs to be confirmed in a further study if these findings translate into long-term clinical benefits. The safety profile of the medicine was considered to be favourable, with side effects that were tolerable and usually resolved in a short time.

The European Medicines Agency therefore decided that Iqirvo’s benefits are greater than its risks and it can be authorised for use in the EU.

Iqirvo has been given conditional authorisation. This means that it has been authorised on the basis of less comprehensive data than are normally required because it fulfils an unmet medical need. The Agency considers that the benefit of having the medicine available earlier outweighs any risks associated with using it while awaiting further evidence.

The company must provide further data on Iqirvo. To confirm the safety and effectiveness of Iqirvo in adults with primary biliary cholangitis, the company must conduct a study to investigate the long-term clinical benefits in patients with primary biliary cholangitis treated with Iqirvo. Every year, the Agency will review any new information that becomes available.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Iqirvo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Iqirvo are continuously monitored. Suspected side effects reported with Iqirvo are carefully evaluated and any necessary action taken to protect patients.