FDA Grants Accelerated Approval to Iqirvo for the Treatment of Primary Biliary Cholangitis
Ipsen has announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.