Posted by Michael Wonder on 11 Jun 2024
Ipsen’s Iqirvo receives US FDA accelerated approval as a first in class PPAR treatment for primary biliary cholangitis
10 June 2024 - Approval based on positive Phase 3 ELATIVE trial data.
Ipsen today announced that the US FDA has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of 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.
