The Saudi Food and Drug Authority (SFDA) has approved the registration of Aikervo "Elafibranor" 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 one of the chronic liver diseases, wherein the bile ducts are progressively destroyed, leading to an obstruction of bile flow to the digestive system, a crucial fluid that aids in digestion, especially fats, resulting in its accumulation in the liver and what is known as cholestasis, leading to liver tissue damage and reduced liver function.
Innovative Mechanism of Action Aikervo contains the active substance "Elafibranor," which works by activating specific receptors within the nucleus of liver cells, contributing to reducing bile acid production and increasing its export from the liver, along with anti-inflammatory and anti-fibrotic effects, which alleviates cholestasis and improves bile flow within the bile ducts.
Positive Clinical Results The authority stated that the approval of the product came after a comprehensive evaluation of its efficacy, safety, and quality, noting that clinical studies showed Aikervo achieved a greater improvement in biochemical response and normalization of alkaline phosphatase (ALP) levels at week 52 compared to placebo. Improvement in enzyme levels was the primary contributing factor to the biochemical response rate, with the majority of patients participating in the study having normal total bilirubin levels.
Common Side Effects The authority indicated that the most common side effects observed in clinical studies included abdominal pain, gastrointestinal disturbances, muscle pain, headache, in addition to some changes in laboratory testing results.
New Approval Enhances Healthcare Quality This approval reflects the authority's commitment to supporting innovation in the healthcare sector and providing modern treatment options for patients, contributing to improving the quality of healthcare, aligned with the objectives of the Health Sector Transformation Program, one of the programs of Saudi Vision 2030.