The Saudi Food and Drug Authority (SFDA) has approved the registration of Iqirvo (Elafibranor) for the treatment of adults with primary biliary cholangitis (PBC) who have had an inadequate response to ursodeoxycholic acid (UDCA) or are unable to tolerate it.

Primary biliary cholangitis is a type of chronic liver disease in which the bile ducts are slowly destroyed, leading to impaired bile flow to the digestive system. Bile is a fluid that helps digest food, especially fats. When the bile cannot flow into the digestive tract, the bile accumulates in the liver, resulting in cholestasis, where it damages liver tissues. This may subsequently cause reduced liver function and liver inflammation.

Innovative Mechanism of Action

Iqirvo contains the active substance Elafibranor, which works by activating the peroxisome proliferator-activated receptor (PPAR)-alpha and PPAR-delta receptors. These proteins are thought to regulate the levels of bile acids, inflammation, and fibrosis, thereby reducing the production and the accumulation of bile acids in the liver and decreasing liver inflammation.

Positive Results Demonstrated in Clinical Studies

Approval was granted following a comprehensive evaluation of the product’s efficacy, safety, and quality by the SFDA. Clinical studies demonstrated that Iqirvo achieved greater improvements in biochemical response and normalization of alkaline phosphatase (ALP) levels at Week 52 compared to placebo. The improvement in ALP levels was the primary contributing factor to the biochemical response rate, as the majority of patients enrolled in the study had normal total bilirubin levels.

Most Common Side Effects

The SFDA noted that the most commonly reported adverse reactions during clinical studies included abdominal pain, gastrointestinal disorders, muscle pain, and headache, as well as certain changes in laboratory test results.

A New Step Toward Enhancing the Quality of Healthcare

This approval reflects the SFDA’s continued commitment to innovation and expanding access to advanced treatment options, thereby enhancing the quality of healthcare in alignment with the goals of the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.