Ipsen Confirms FDA Grants Priority Review For New Drug Application For Elafibranor For The Treatment Of Rare Cholestatic Liver Disease, PBC

Author: Charles Gross | December 07, 2023 06:17am

Ipsen ((Euronext: IPN, OTC:IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade. The target FDA PDUFA date under priority review is June 10, 2024.

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