GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA Accelerated Approval
GENFIT S.A. - American Depositary Shares (GNFT)
Company Research
Source: GlobeNewswire
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), September 23, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. This follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 26, 2024 and the U.S. FDA Accelerated Approval on June, 10, 2024 . Pascal Prigent, CEO of GENFIT, commented: “The approval of Iqirvo in the EU is another landmark moment for GENFIT. Iqirvo’s EU approval provides further validation of our scientific and clinical cap
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- Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus [Yahoo! Finance]Yahoo! Finance
- GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024 [Yahoo! Finance]Yahoo! Finance
- GENFIT Announces Corporate Updates and Upcoming Participation at The Liver Meeting® 2024GlobeNewswire
- GENFIT Reports Third Quarter 2024 Financial Information [Yahoo! Finance]Yahoo! Finance
- GENFIT Reports Third Quarter 2024 Financial InformationGlobeNewswire