JUNE 12, 2024

FDA Approves Elafibranor for Primary Biliary Cholangitis

The FDA granted accelerated approval for elafibranor (Iqirvo, Ipsen), a peroxisome proliferator−activated receptor agonist, for patients with primary biliary cholangitis (PBC). The 80-mg tablet is indicated for use in combination with ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA alone, or as monotherapy for patients who cannot tolerate UDCA. The drug is not available for patients with decompensated cirrhosis.

The approval follows positive results in the phase