The Food and Drug Administration approves the registration of the drug “Acervo” for the treatment of primary biliary cholangitis

The Saudi Food and Drug Authority has approved the registration of Akervo “Elafipranor” preparation for the treatment of adults with primary biliary cholangitis, who have not responded adequately to ursodeoxycholic acid or are unable to tolerate it. This disease is considered a chronic liver disease, in which the bile ducts are gradually destroyed, leading to obstruction of the flow of bile into the digestive system, which is an important fluid that helps digest food, especially fats, which leads to its accumulation in the liver and the occurrence of what is known as cholestasis, which results in damage to liver tissue and a decrease in its functions.
The Ikervo preparation contains the active ingredient “elafipranor”, ​​which works by activating certain receptors within the nucleus in liver cells, which contributes to reducing the production of bile acids and increasing their export from the liver, in addition to anti-inflammatory and anti-cirrhotic effects, which leads to alleviating bile stasis and improving the flow of bile within the bile ducts. The authority explained that the approval of the preparation came after a comprehensive evaluation of its effectiveness, safety and quality, noting that clinical studies showed that Acervo achieved a greater improvement in the biochemical response and normalization of alkaline phosphatase (ALP) levels at the fifty-second week compared to placebo.
Improvement in enzyme levels was the main contributing factor to the biochemical response rate results, as the majority of patients in the study had normal total bilirubin levels. She pointed out that the most common side effects that appeared in clinical studies included abdominal pain, digestive system disorders, muscle pain, and headache, in addition to some changes in the results of laboratory tests.

This accreditation reflects the Authority’s commitment to supporting innovation in the health sector and providing modern treatment options for patients, which contributes to improving the quality of health care, in line with the objectives of the Health Sector Transformation Program, one of the programs of the Kingdom’s Vision 2030.