Genfit: positive CHMP opinion for Iqirvo to treat PBC

(CercleFinance.com) - Genfit today announced the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Ipsen's Iqirvo (elafibranor) in the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients who cannot tolerate UDCA.


Elafibranor, a first-in-class molecule marketed in the U.S. by Ipsen under the brand name Iqirvo since June 2024, was developed by Genfit from initial discovery through to completion of the 52-week Phase 3 clinical trial.

Genfit has licensed to Ipsen exclusive worldwide rights (excluding China, Hong Kong, Taiwan and Macau) to operate elafibranor in 2021.

The European Commission will now review the CHMP's recommendations.
A final decision on marketing authorization for Iqirvo is expected in the second half of 2024.


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