Ipsen (Euronext: IPN; ADR: IPSEY) has announced that the European Commission has granted conditional approval for Iqirvo® (elafibranor) 80mg tablets. Iqirvo is approved for the treatment of primary biliary cholangitis (PBC) in adults, either in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA, or as a monotherapy for patients who cannot tolerate UDCA. Iqirvo is a first-in-class, oral peroxisome proliferator-activated receptor (PPAR) agonist, targeting the proteins PPARα and PPARδ, which play key roles in regulating bile acid, inflammation, and fibrosis.
“We are thrilled that Iqirvo has been approved in the EU as a new treatment option for people with PBC,” said Sandra Silvestri, Chief Medical Officer at Ipsen. “PBC is a rare liver disease, primarily affecting women, and there hasn’t been any innovation in this space for almost a decade. Many patients are intolerant or do not respond to current therapies, and for those at risk of disease progression, Iqirvo offers a much-needed alternative.”
The approval is based on data from the phase III ELATIVE1 trial, which showed a significant benefit from Iqirvo. The trial demonstrated a 47% placebo-adjusted difference (P<0.001) in achieving a biochemical response, with 51% of patients on Iqirvo showing improvement, compared to just 4% on placebo. Although a greater reduction in itch severity (PBC Worst Itch-NRS score) was observed in patients taking Iqirvo compared to placebo, the difference was not statistically significant. However, improvements in pruritus were noted, as shown by reductions in the PBC-40 itch and 5-D itch scores. The incidence of adverse events was comparable between the Iqirvo and placebo groups.
Dr. Marco Carbone, Professor of Gastroenterology at the University of Milano-Bicocca and Consultant Hepatologist at the Niguarda Liver Transplant Centre in Milan, expressed optimism about the approval: “PBC is a progressive liver disease that can lead to liver failure or the need for a liver transplant. This new treatment, which has shown potential in managing disease progression and reducing debilitating symptoms like itch, is a significant step forward for both doctors and patients.”
Patient Advocate Sindee Weinbaum from the European Liver Patients’ Association emphasized the importance of personalized treatment: “PBC affects individuals differently, with some experiencing severe symptoms like fatigue or itching, while others may show no symptoms but have poor biomarker levels. It’s essential for patients to work with their doctors to tailor treatments to their specific needs. The approval of Iqirvo is great news for those struggling to manage their condition.
