Ipsen: Iqirvo approved for PBC in the EU

(CercleFinance.com) - Ipsen announces that the European Commission has granted conditional marketing authorization to Iqirvo (elafibranor), a new first-in-class treatment for primary biliary cholangitis (PBC), a rare liver disease.


The product has been conditionally approved for the treatment of PBC in combination with ursodeoxycholic acid (AUDC) in adults with an inadequate response to AUDC, or as monotherapy in patients intolerant to AUDC.

The approval follows the CHMP's positive opinion based on data from the Phase III ELATIVE trial, which demonstrated significant efficacy versus placebo, as well as an acceptable safety profile", says the company.

This decision, which makes Iqirvo the first new treatment for PBC in nearly a decade, 'reinforces Ipsen's commitment to developing innovative treatments for people with rare cholestatic liver diseases'.

Copyright (c) 2024 CercleFinance.com. All rights reserved.