Ipsen and Genfit Secure FDA Approval for Iqirvo, a Breakthrough Treatment for Primary Biliary Cholangitis

1. FDA Approval: The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ipsen and Genfit's Iqirvo (elafibranor) for the treatment of primary biliary cholangitis (PBC).
2. First New Medicine in a Decade: Iqirvo is the first new medicine approved for PBC in nearly a decade, offering a significant advancement in the treatment of this rare liver disease.
3. Indication: Iqirvo is indicated for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
4. Mechanism: Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist, although the exact mechanism is not fully understood.
5. Competitive Landscape: Iqirvo will compete with Intercept's Ocaliva, another treatment option for PBC.
6. Potential Impact: Iqirvo may improve biochemical responses in patients with PBC, potentially preventing liver decompensation events and improving survival rates.
7. Future Trials: Continued approval for Iqirvo may be contingent on confirmatory trials demonstrating clinical benefit.
8. Global Prevalence: PBC affects approximately 100,000 people in the U.S. and is growing in global prevalence, making Iqirvo a significant addition to the treatment landscape.