https://gastroenterology.acponline.org/archives/2024/06/28/12.htm

New medication approved for primary biliary cholangitis

The FDA recently approved elafibranor oral tablets (Iqirvo) for primary biliary cholangitis.


The FDA recently approved elafibranor oral tablets (Iqirvo) for primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Patients who have or who develop decompensated cirrhosis should not use elafibranor. Physicians should also verify that patients are not pregnant prior to starting the treatment, inform them of the potential risk to a fetus, and advise the use of effective contraception.