GENFIT Secures EU Approval for Iqirvo®
GENFIT, a leading biopharmaceutical firm, has proudly announced that it received conditional approval from the European Commission for its medication Iqirvo® (elafibranor) at an 80mg dosage. This remarkable treatment is tailored for adults dealing with Primary Biliary Cholangitis (PBC) and is intended to be used in conjunction with ursodeoxycholic acid (UDCA), or on its own for those who cannot tolerate UDCA.
Importance of the Approval
The approval of Iqirvo represents a significant achievement for GENFIT, reflecting its commitment to tackling rare liver diseases. Pascal Prigent, the CEO of GENFIT, emphasized that securing EU approval highlights the company’s scientific strength and its drive to enhance treatment options. This important milestone also includes a potential €26.5 million payment once Iqirvo is priced and reimbursed in three European countries, enabling GENFIT to expand its efforts in addressing serious liver conditions.
Partnership with Ipsen
Since June 2024, the innovative treatment elafibranor has been managed commercially by Ipsen in the United States. GENFIT has been involved with this molecule from its initial discovery through to the successful completion of a 52-week Phase 3 clinical trial, which showcases the company's development expertise.
Clinical Foundation
The journey to approval was supported by extensive clinical studies demonstrating positive outcomes for patients with PBC. The favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) was a key turning point that led to this major European approval.
Product Information
Iqirvo's approval is a vital step in meeting the unmet medical needs of those affected by PBC. Comprehensive safety guidelines and usage details for Iqirvo can be found in the Summary of Product Characteristics (SmPC), which is available in all official EU languages.
About GENFIT
Established over 20 years ago, GENFIT has made a name for itself in liver disease research and the development of therapies. The company is committed to enhancing patient lives through innovative approaches. GENFIT focuses particularly on Acute-On-Chronic Liver Failure (ACLF), working on five development assets in this area, while also targeting conditions such as cholangiocarcinoma (CCA) and organic acidemia (OA).
Dedication to Research
GENFIT's dedication to research is clear in its ongoing efforts to address various liver diseases that still lack adequate treatment options. With projects that range from drug development to diagnostics, GENFIT demonstrates a holistic approach to tackling these persistent health issues.
Final Thoughts
The EU approval for Iqirvo® marks not only a significant milestone for GENFIT but also brings hope to patients fighting liver diseases. Armed with extensive research and clinical validation, GENFIT is ready to introduce Iqirvo to the European market, potentially reshaping the landscape of PBC treatment.
Frequently Asked Questions
What is Iqirvo® approved for?
Iqirvo® (elafibranor) is approved for the treatment of Primary Biliary Cholangitis in adults who do not respond adequately to UDCA.
Who developed Iqirvo®?
Iqirvo® was developed by GENFIT and is commercially managed by Ipsen in the United States.
What does the €26.5 million milestone entail?
This milestone payment hinges on Iqirvo's pricing and reimbursement in European nations, allowing GENFIT to further its pipeline development.
What conditions does GENFIT focus on?
GENFIT focuses on Rare Liver Diseases and is currently working on treatments for Acute-On-Chronic Liver Failure and other liver-related disorders.
How can patients access Iqirvo®?
The treatment will be available in Europe after it completes the pricing and reimbursement process, specifically for patients with PBC.
