GENFIT: Ipsen’s Iqirvo® (Elafibranor) Approved in EU for Primary Biliary Cholangitis after U.S. FDA Accelerated Approval

On September 23, 2024, GENFIT, a biopharmaceutical company focused on rare and life-threatening liver diseases, announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for treating Primary Biliary Cholangitis (PBC). This approval is for use in combination with ursodeoxycholic acid (UDCA) for adults who have an inadequate response to UDCA or as a monotherapy for those who cannot tolerate UDCA. This decision follows the positive opinion from 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 granted on June 10, 2024.

Pascal Prigent, CEO of GENFIT, expressed his enthusiasm about Iqirvo's approval in the EU, highlighting it as a significant milestone for GENFIT. He emphasized that this approval validates their scientific and clinical capabilities, marking Iqirvo as a new treatment option for patients. Prigent also mentioned that the anticipated €26.5 million milestone payment upon Iqirvo’s pricing and reimbursement approval in three European countries would bolster their efforts in developing a robust pipeline for other severe liver diseases with high unmet needs, including Acute On-Chronic Liver Failure.

Elafibranor, marketed in the United States under the trademark Iqirvo since June 2024 by Ipsen, was developed by GENFIT from its initial discovery through a 52-week Phase 3 clinical study. Ipsen obtained exclusive worldwide rights (excluding China, Hong Kong, Taiwan, and Macau) to elafibranor from GENFIT in 2021. Important safety information and recommendations for Iqirvo's use are detailed in the Summary of Product Characteristics (SmPC), available in the European public assessment report (EPAR) and published in all official EU languages. The full SmPC can be accessed on the European Medicines Agency's website.

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, whose medical needs are largely unmet. With a rich history and a strong scientific foundation spanning more than two decades, GENFIT has established a diverse and rapidly expanding R&D portfolio. The company's primary focus is on Acute-on-Chronic Liver Failure (ACLF), with five assets under development: VS-01, NTZ, SRT-015, CLM-022, and VS-02-HE, each based on complementary mechanisms of action and different routes of administration. Additionally, GENFIT is working on treatments for other serious conditions, including cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA).

GENFIT's expertise in developing high-potential molecules from early stages to pre-commercialization was demonstrated by the FDA’s accelerated approval of Iqirvo® (elafibranor2) for Primary Biliary Cholangitis (PBC). Beyond therapeutic developments, GENFIT has a diagnostic franchise, including NIS2+® for Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH) and TS-01, which focuses on blood ammonia levels. Headquartered in Lille, France, GENFIT also has offices in Paris, Zurich, and Cambridge, MA. The company is listed on the Nasdaq Global Select Market and the Euronext regulated market in Paris, Compartment B. In 2021, Ipsen acquired an 8% stake in GENFIT, becoming one of its largest shareholders.