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New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in PBC
New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in
About this update from Iqvia Holdings, Inc.
[{"type":"text","content":" IQIRVO® data expands scientific evidence in fatigue, showing clinically meaningful improvements in patients with moderate-to-severe fatigue at baselineIn the first real-world analysis in patients with PBC and an ALP 1-1.67 x ULN, IQIRVO demonstrated a significant ALP reduction, with 59% of patients achieving ALP normalization at 6 monthsInterim analysis from the ELFINITY Phase IV study highlights real-world effectiveness and tolerability of IQIRVO in both biochemical and symptom control, including fatigue and pruritusPARIS, FRANCE, 28 MAY 2026 - Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of new late-breaking results from the ELATIVE® Phase III trial and two real-world studies at the European Association for the Study of the Liver (EASL) congress. Together, these data further strengthen the growing body of evidence establishing IQIRVO® as the only second-line primary biliary cholangitis (PBC) treatment providing rapid and robust alkaline phosphatase (ALP) reduction with fatigue improvement (in patients with moderate-to-severe fatigue at baseline) and pruritus relief. In a post hoc analysis of the pivotal ELATIVE study, shared in a late-breaking presentation, patients with moderate-to-severe fatigue at baseline experienced greater fatigue reductions with IQIRVO compared to placebo across 52 weeks. A clinically meaningful improvement in fatigue was achieved in 67% of patients on IQIRVO vs 31% on placebo (p=0.020) at Week 52, with improvements observed as early as Week 4. The benefits of IQIRVO vs placebo were observed across multiple dimensions of physical and mental fatigue, including extreme exhaustion (62% vs 31%), too tired to think clearly (57% vs 31%) and too tired to bath or shower (55% vs 25%), highlighting the breadth of improvement across several symptom domains. “Fatigue is one of the most debilitating symptoms of PBC and has long represented a significant unmet need for patients and clinicians,” said David Jones, Professor of Liver Immunology for the Faculty of Medical Science at Newcastle University. “These data are particularly encouraging, showing that IQIRVO led to clinically meaningful improvements in fatigue compared with placebo. Importantly, improvements were seen across multiple dimensions of fatigue, including outcomes that matter most to patients.” In a second late-breaking ...