Genfit announces positive CHMP opinion for Ipsen’s Iqirvo

GENFIT (GNFT) announced the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency’s for Ipsen’s (IPSEY) Iqirvo for the treatment of Primary Biliary Cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Elafibranor, a molecule marketed and commercialized in the United States by Ipsen under the trademark Iqirvo since June 2024, was developed by GENFIT, from initial discovery to the conclusion of a 52-week Phase 3 clinical study. Ipsen licensed the exclusive worldwide rights to elafibranor from GENFIT in 2021. The European Commission will now consider the CHMP recommendations, and a final decision on marketing authorization for Iqirvo is anticipated in the second half of 2024.