IPSEY - GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo® for Primary Biliary Cholangitis | Benzinga
- 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, OTC: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.
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IMPORTANT SAFETY INFORMATION
Myalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor (statin). Myalgia or myopathy, with or without CPK elevations, occurred in patients treated with IQIRVO alone or treated concomitantly with a stable dose of an HMG-CoA reductase inhibitor. Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis.
Fractures: Fractures occurred in 7% of IQIRVO-treated patients compared to 0% in placebo-treated patients. Consider the risk of fracture in the care of patients treated with IQIRVO and monitor bone health according to current standards of care.
Adverse Effects on Fetal and Newborn Development: IQIRVO may cause fetal harm when administered during pregnancy. For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy. Advise females of reproductive potential to use effective non-hormonal contraceptives or add a barrier method when using systemic hormonal contraceptives during treatment with IQIRVO and for 3 weeks following the last dose of IQIRVO.
Drug-Induced Liver Injury: Suspected drug-induced liver injury occurred in one patient who took IQIRVO 80 mg once daily and two patients who took IQIRVO at 1.5-times the recommended dosage, of which one presented with autoimmune-like hepatitis. The median time to onset of elevation in liver tests was 85 days. Obtain baseline clinical, laboratory and imaging assessments at treatment initiation with IQIRVO and monitor thereafter according to routine patient management. Interrupt IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting IQIRVO.
Hypersensitivity Reactions: Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1.5-times the recommended dosage. Three patients (0.2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation. Hypersensitivity reactions resolved after discontinuation of IQIRVO and treatment with steroids and/or antihistamines. If a severe hypersensitivity reaction occurs, permanently discontinue IQIRVO. If a mild ...