Genfit: filing for elafibranor accepted by the FDA

(CercleFinance.com) - Ipsen and Genfit announce that the U.
S. Food and Drug Administration (FDA) has accepted for filing the Investigational New Drug application for elafibranor. The PDUFA target date for the FDA, which is currently conducting a priority review, is June 10, 2024.

'The investigational once-daily oral drug could become the first new second-line treatment for primary biliary cholangitis, a rare cholestatic liver disease, in nearly a decade', they point out.

The European Medicines Agency has also approved elafibranor's marketing authorization application. In addition, a third application for regulatory approval has been validated for review by the MHRA in the UK.

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