Key Takeaways
- Elafibranor (Iqirvo) is now approved by the MHRA to treat adults with primary biliary cholangitis (PBC), a rare chronic liver disease.
- The medicine works by reducing bile acid production and inflammation, improving liver function.
- Approval was based on a study showing elafibranor’s significant effectiveness compared to placebo in reducing liver damage markers.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved elafibranor (marketed as Iqirvo) as the first medicine to treat adults with primary biliary cholangitis (PBC), a rare and progressive liver disease. PBC causes inflammation and destruction of small bile ducts in the liver, which leads to a buildup of bile and can result in liver damage or failure if left untreated. Elafibranor’s approval offers a new treatment option for patients suffering from this chronic condition.
Elafibranor helps to improve liver function by reducing bile acid production and preventing the harmful buildup of bile, as well as minimizing liver inflammation. The recommended dose is one tablet, taken once daily, and it can be used alone or alongside ursodeoxycholic acid (UDCA), another treatment for PBC.
Efficacy on Biliary Cholangitis Based on Clinical Trials
The approval of elafibranor was supported by data from a placebo-controlled study involving 161 adults with PBC. Most participants had been on UDCA for at least a year, though some had discontinued due to side effects. The study evaluated the effectiveness of elafibranor in reducing Alkaline Phosphatase (ALP) and bilirubin—key markers of liver damage. Results showed that 51% of patients treated with elafibranor saw a significant reduction in ALP and bilirubin levels, compared to just 4% in the placebo group. This demonstrated the clear benefit of elafibranor in improving liver health.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, commented, “Enabling access to safe and effective treatments is one of our top priorities. Elafibranor has met the necessary standards for safety and effectiveness, and we will continue to closely monitor its use.”
Monitoring and Side Effects
As with all new medicines, the MHRA will keep the safety of elafibranor under close review. Patients using elafibranor are encouraged to report any side effects to their healthcare provider or directly to the MHRA’s Yellow Card scheme.
Common side effects are listed in the product’s patient information leaflet, available through the MHRA website.The availability of elafibranor marks a significant step forward in treating PBC, offering patients a new way to manage this challenging condition and prevent serious liver complications.
Resource: The Medicines and Healthcare products Regulatory Agency, October 08, 2024
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