"FDA Approves Breakthrough Drug for Primary Biliary Cholangitis"
The FDA has approved Ipsen's new drug Iqirvo (elafibranor) for treating primary biliary cholangitis (PBC), an autoimmune liver disease. This oral medication offers a new treatment option for patients who do not respond to or cannot tolerate the existing drug, ursodeoxycholic acid (UDCA). The approval is based on positive results from a Phase III trial showing significant improvements in liver enzyme levels. However, potential side effects include muscle pain and liver injury, and it is not recommended for pregnant patients or those with advanced cirrhosis.