Latest FDA approved drug Elafibranor (Iqirvo): a novel prospect for treatment of primary biliary cholangitis.

Abstract

Elafibranor (Iqirvo) has recently received FDA approval for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). This novel drug, a dual peroxisome proliferator-activated receptor-α/δ agonist, addresses the unmet need in PBC patients unresponsive to UDCA alone. Clinical trials, particularly the ELATIVE study, have shown significant biochemical improvements, including reduced alkaline phosphatase (ALP) levels and optimized lipid profiles. While common side effects include gastrointestinal discomfort, more severe but rare adverse effects, such as muscle injury and new-onset cholelithiasis, were observed. Elafibranor represents a promising advance in PBC management, offering enhanced efficacy with a tolerable safety profile. However, further research is needed to assess its long-term effectiveness and safety.