(RTTNews) - Ipsen (IPSEY) and GENFIT said that the U.S. Food and Drug Administration has accepted the New Drug Application (NDA) for investigational elafibranor.
An oral, once-daily dual peroxisome activated receptor alpha/delta agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, primary biliary cholangitis or PBC, in nearly a decade.
The target FDA PDUFA date under priority review is June 10, 2024.
The European Medicines Agency has also validated Ipsen's Marketing Authorization Application for elafibranor and the review of the submission to the EMA's Committee for Medicinal Products for Human Use (CHMP) began on 26 October 2023.
In addition, a third simultaneous regulatory filing of elafibranor has been validated for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
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