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Review
. 2024 Sep;84(9):1143-1148.
doi: 10.1007/s40265-024-02075-8. Epub 2024 Aug 7.

Elafibranor: First Approval

Hannah A Blair  1
Affiliations
Review

Elafibranor: First Approval

Hannah A Blair. Drugs. 2024 Sep.

Erratum in

Abstract

Elafibranor (IQIRVO®) is a first-in-class peroxisome proliferator-activated receptor (PPAR) agonist being developed by Ipsen, under license from Genfit, for the treatment of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). On 10 June 2024, elafibranor received accelerated approval based on reduction of alkaline phosphatase (ALP) in the USA for the treatment of 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. Elafibranor has also received a positive opinion in the EU. This article summarizes the milestones in the development of elafibranor leading to this first approval for PBC.

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References

    1. Schnabl B. PPAR agonists in primary biliary cholangitis. N Engl J Med. 2024;390(9):855–8. - DOI - PubMed
    1. You H, Duan W, Li S, et al. Guidelines on the diagnosis and management of primary biliary cholangitis (2021). J Clin Transl Hepatol. 2023;11(3):736–46. - PubMed - PMC
    1. Genfit. FDA and EMA grant Genfit’s elafibranor orphan drug designation for primary biliary cholangitis (PBC) [media release]. 29 Jul 2019. http://www.genfit.com .
    1. Genfit. Genfit announces FDA grant of breakthrough therapy designation to elafibranor for the treatment of PBC [media release]. 18 Apr 2019. http://www.genfit.com .
    1. Genfit. Genfit upates 2024 outlook following acceptance of elafibranor filings in primary biliary cholangitis (PBC) [media release]. 8 Dec 2023. http://www.genfit.com .

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