GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary Cholangitis
June 10, 2024
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Ipsen’s Iqirvo® (elafibranor) 80 mg tablets receives U.S. FDA accelerated approval as a first-in-class treatment for Primary Biliary Cholangitis (PBC)
First-ever drug developed in-house by GENFIT to achieve U.S. FDA’s approval
GENFIT is eligible to receive a €48.7 million milestone payment from Ipsen upon the first commercial sale of Iqirvo in the U.S., as well as tiered double-digit royalties of up to 20%
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), June 10, 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 the achievement of a historic corporate milestone: the U.S. Food and Drug Administration (FDA) accelerated approval of Iqirvo1 (elafibranor)2 80 mg tablets – as unveiled today by Ipsen (Euronext: IPN; ADR: IPSEY) – as a first-in-class treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Elafibranor will be marketed and commercialized by Ipsen under the trademark Iqirvo and may be prescribed immediately in the U.S. for eligible patients.
This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Iqirvo is not recommended for people who have or who develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
Pascal Prigent, CEO of GENFIT, commented: “This approval is a source of pride for all GENFIT employees. We took elafibranor (Iqirvo) all the way from drug discovery to the end of Phase 3 and now, thanks to our partnership with Ipsen, it will be made available to healthcare providers in the US and ultimately provide patients with a valuable therapeutic alternative. The upcoming launch is both a major achievement and the beginning of a new chapter, as we expect that the revenues derived from the commercialization of elafibranor will now finance the development of a new and exciting portfolio of programs focused on ACLF.”
In 2024, as previously communicated, GENFIT expects to receive total milestone payments from Ipsen of approximately €89 million, including €48.7 million upon the first commercial sale of Iqirvo in the U.S., and a €13.3 million milestone payment which was invoiced in December 2023, and received in February 2024.
These revenues present GENFIT with new financial opportunities and will help to finance our strategic pivot towards Acute on-Chronic Liver Failure (ACLF) and other liver diseases.