GENFIT Celebrates EU Approval of Iqirvo® for Liver Disease Treatment
GENFIT Celebrates New Milestone with Iqirvo® Approval
GENFIT, a biopharmaceutical company, recently achieved a significant milestone with the conditional approval of Iqirvo® (elafibranor) 80mg tablets by the European Commission. This approval is specifically for the treatment of Primary Biliary Cholangitis (PBC), either in combination with ursodeoxycholic acid (UDCA) or as a standalone therapy for patients intolerant to UDCA. This development marks a promising advancement in the management of a condition that affects numerous individuals across Europe.
CEO's Insights on the Approval
Pascal Prigent, the CEO of GENFIT, expressed his enthusiasm regarding the approval. He noted, "The approval of Iqirvo in the EU is another landmark moment for GENFIT. It validates our scientific and clinical capabilities and highlights our journey in bringing Iqirvo from its initial discovery to this point." He emphasized how Iqirvo now stands as a vital new treatment option for patients suffering from PBC.
Financial Impact of Iqirvo's Approval
The anticipated milestone payment of €26.5 million following Iqirvo’s pricing and reimbursement approval reflects GENFIT's strong position to further enhance its pipeline, particularly for severe liver diseases with high unmet needs, such as Acute On-Chronic Liver Failure.
Background on Elafibranor
Elafibranor is noteworthy for being a 'first-in-class' drug, specifically designed to tackle PBC. Since June 2024, it has been marketed and commercialized in the U.S. by Ipsen under the Iqirvo name. GENFIT developed elafibranor from the ground up, navigating through rigorous clinical studies which culminated in a successful 52-week Phase 3 clinical trial. The exclusive worldwide rights to elafibranor were granted to Ipsen by GENFIT in 2021, excluding certain territories such as China and Hong Kong.
Implications for Liver Disease Patients
This approval is particularly significant for individuals with Primary Biliary Cholangitis, a chronic autoimmune disease that can lead to serious liver complications if left untreated. By offering Iqirvo as an alternative treatment, patients now have more options to manage their condition effectively.
The Broader GENFIT Mission
GENFIT remains committed to enhancing the lives of patients with rare and severe liver diseases. With a rich history of innovation spanning two decades, the company is well-positioned to lead in liver disease research and development. Their portfolio spans various stages of research and includes multiple promising assets designed to address unmet medical needs.
An Overview of GENFIT's R&D Portfolio
GENFIT’s ambitions extend beyond just the approval of Iqirvo. The company is actively involved in research initiatives targeting Acute-on-Chronic Liver Failure (ACLF), with five assets currently under development. These include VS-01, NTZ, SRT-015, CLM-022, and VS-02-HE, each designed to leverage unique mechanisms of action. GENFIT is also exploring treatments for other serious conditions, such as cholangiocarcinoma, urea cycle disorder, and organic acidemia.
Conclusion and Future Outlook
With the EU's conditional approval of Iqirvo, GENFIT sets the stage for continued progress in liver disease treatment. This advancement not only underscores the company’s commitment to patient care but also positions it for future innovations. As GENFIT continues to develop its pipeline and explore new therapeutic avenues, the future looks promising for both the company and those affected by liver diseases.
Frequently Asked Questions
What is Iqirvo® used for?
Iqirvo® is approved for the treatment of Primary Biliary Cholangitis (PBC) in adults, either with UDCA or as a monotherapy.
What are the implications of the EU approval for patients?
The EU approval of Iqirvo® provides patients with additional treatment options, potentially improving their management of PBC.
Who developed elafibranor?
Elafibranor was developed by GENFIT and is marketed in the U.S. by Ipsen under the Iqirvo® trademark.
What is GENFIT's focus aside from PBC?
GENFIT is also focusing on other severe liver conditions, including Acute On-Chronic Liver Failure and various rare liver diseases.
How can I find more information about GENFIT's developments?
Further updates and information can be found on GENFIT's official website and their public assessments regarding drug approvals and research.
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