Basic Information
Iqirvo
Regulatory Information
EMEA/H/C/006231
September 19, 2024
July 25, 2024
1
September 20, 2024
Company Information
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Overview Summary
Iqirvo is used to treat adults with a liver disease known as primary biliary cholangitis. Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the bile ducts in the liver. These ducts transport fluid called bile from the liver to the intestines, where it is used to help digest fats. As a result of the damage to the ducts, bile builds up in the liver causing damage to liver tissue. This may lead to scarring and liver failure and may increase the risk of liver cancer. Iqirvo is used together with another medicine, ursodeoxycholic acid (UDCA), in patients for whom UDCA alone does not work well enough, and on its own in patients who cannot take UDCA. Primary biliary cholangitis is rare, and Iqirvo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 25 July 2019. Further information on the orphan designation can be found on the EMA [website](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-19-2182). Iqirvo contains the active substance elafibranor.