Ipsen Reports Positive Three-Year Iqirvo Results for Primary Biliary Cholangitis: A Breakthrough in Treatment

Positive Results for Iqirvo in Treating Primary Biliary Cholangitis

Ipsen reported encouraging results for Iqirvo (elafibranor), a treatment for primary biliary cholangitis (PBC), a rare liver disease. Interim data from a three-year study were presented at the American Association for the Study of Liver Disease congress.

In this study, 138 patients who completed the initial double-blind phase of the phase 3 ELATIVE study showed significant improvements after three years on Iqirvo. Of these patients, 85% had a biochemical response, and 39% achieved normal alkaline phosphatase (ALP) levels by week 156.

Patients with moderate to severe itching also reported lasting reductions in pruritus during the study. Additional markers indicated liver fibrosis stabilization from the start of treatment to week 130.

PBC affects around 100,000 people in the US, primarily women. It leads to chronic symptoms like itching and fatigue, which can worsen over time. Poorly managed PBC may result in liver transplants or even death.

Iqirvo is an oral medication taken once daily. It works as a peroxisome proliferator-activated receptor agonist, helping to lower bile toxicity and improve cholestasis by influencing bile acid processes.

Kris Kowdley, a lead investigator in the ELATIVE study, expressed satisfaction with the results, noting the importance of improved quality of life for patients.

The positive results follow a recent recommendation by the National Institute for Health and Care Excellence for Iqirvo’s use in combination with ursodeoxycholic acid (UDCA) for adult PBC patients who do not respond to UDCA. Iqirvo was also approved by the US Food and Drug Administration and the European Commission earlier this year.