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GENFIT announced the achievement of a historic corporate milestone: the U.S. Food and Drug Administration accelerated approval of Iqirvo1 2 80 mg tablets – as unveiled today by Ipsen – as a first-in-class treatment for PBC in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.

Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

In its second antibody-drug conjugate licensing agreement this year, Ipsen has secured exclusive rights to Foreseen Biotechnology’s FS001, which targets a novel antigen expressed across a range of solid tumors.

Gilead Sciences’ primary biliary cholangitis candidate seladelpar and Ipsen’s PBC asset elafibranor both showed encouraging Phase III results Wednesday, as they face looming FDA decision dates.