GENFIT Achieves Milestone with EU Approval for Iqirvo®
GENFIT Announces EU Approval for Iqirvo®
GENFIT, a prominent biopharmaceutical company, has received a conditional approval from the European Commission for its drug Iqirvo® (elafibranor) at a dosage of 80mg. This innovative treatment is specifically designed for adults facing challenges with Primary Biliary Cholangitis (PBC) and aims to be used alongside ursodeoxycholic acid (UDCA) or as a standalone option for those who cannot tolerate UDCA.
Significance of the Approval
The approval of Iqirvo marks a pivotal moment for GENFIT, underscoring its commitment to addressing rare liver diseases. According to Pascal Prigent, CEO of GENFIT, achieving EU approval showcases the company's scientific prowess and dedication to advancing treatment options. This milestone includes a potential €26.5 million payment once Iqirvo is priced and reimbursed in three European nations, allowing GENFIT to further its mission of tackling serious liver conditions.
Collaboration with Ipsen
Elafibranor, a groundbreaking treatment, is under the commercial management of Ipsen in the United States since June 2024. GENFIT has cultivated this molecule from initial discovery to the successful completion of a 52-week Phase 3 clinical trial, solidifying its development capabilities.
Underlying Clinical Studies
The path to approval involved comprehensive clinical studies that illustrated effective outcomes for patients with PBC. The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) was a cornerstone moment, leading to this significant European approval.
About the Product
Iqirvo's approval is a crucial step toward addressing the unmet medical needs of patients suffering from PBC. Detailed safety guidelines and usage information for Iqirvo are accessible in the Summary of Product Characteristics (SmPC), which is made available in all official EU languages.
About GENFIT
Founded over two decades ago, GENFIT has established itself as a leader in liver disease research and therapeutic development. The company is dedicated to improving the lives of patients through innovative solutions. GENFIT is particularly focused on Acute-On-Chronic Liver Failure (ACLF) with five development assets in this area, alongside targeting conditions like cholangiocarcinoma (CCA) and organic acidemia (OA).
Commitment to Innovation
GENFIT's commitment to research is evident in its ongoing projects aimed at addressing various liver diseases, which remain largely underserved in terms of treatment options. With initiatives extending from drug development to diagnostics, GENFIT showcases its comprehensive approach to tackling these persistent health challenges.
Conclusion
The EU approval for Iqirvo® is not just a milestone for GENFIT but also offers hope for patients battling liver diseases. With extensive research and clinical validation backing the treatment, GENFIT stands poised to launch Iqirvo into the European market, potentially transforming the landscape of PBC therapy.
Frequently Asked Questions
What is Iqirvo® approved for?
Iqirvo® (elafibranor) is approved for treating Primary Biliary Cholangitis in adults with inadequate response to UDCA.
Who developed Iqirvo®?
Iqirvo® was developed by GENFIT and is commercially managed by Ipsen in the United States.
What are the implications of the €26.5 million milestone?
The milestone payment is contingent upon Iqirvo's pricing and reimbursement in European countries, enabling GENFIT to advance its pipeline further.
What diseases is GENFIT focused on?
GENFIT primarily focuses on Rare Liver Diseases and is currently developing treatments for Acute-On-Chronic Liver Failure and other liver-related conditions.
How can patients access Iqirvo®?
The treatment will be available in Europe following the pricing and reimbursement process, catering to patients with PBC.
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