Biopharmaceutical company GENFIT (Nasdaq:GNFT) (Euronext Paris:GNFT) announced on Monday that the European Commission has approved Iqirvo (elafibranor) for the treatment of Primary Biliary Cholangitis (PBC).
Iqirvo is a first-in-class molecule developed by GENFIT and licensed to biopharmaceutical company Ipsen (Euronext Paris:IPN) (ADR:IPSEY) in 2021.
This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2024 and accelerated approval from the US Food and Drug Administration (FDA) in June 2024.
GENFIT expects to receive a EUR26.5m milestone payment upon Iqirvo's pricing and reimbursement approval in three European countries.
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