Ipsen's Iqirvo Secures FDA Accelerated Approval For Primary Biliary Cholangitis Treatment

(RTTNews) - The U.S. Food and Drug Administration has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis or PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate ursodeoxycholic acid, Ipsen (IPSEY) said in a statement.

The company noted that Iqirvo is not recommended for people who have or develop decompensated cirrhosis, e.g., ascites, variceal bleeding, hepatic encephalopathy.

Iqirvo has been submitted to the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), seeking authorization for PBC, with final EMA and MHRA regulatory decisions anticipated in the second half of 2024.

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