Late-breaking data from EASL reinforces IQIRVO’s impact on ALP reduction with fatigue and pruritus improvement in patients with PBC
Three late-breaking abstracts accepted, including:
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- Real-world benefit of IQIRVO® (elafibranor) in PBC patients with Alkaline Phosphatase (ALP) 1-1.67 x Upper Limit of Normal (ULN) and on fatigue and pruritus symptoms
- ELATIVE Phase III trial data on the impact of IQIRVO on PBC fatigue
PARIS, FRANCE, 15 MAY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today the latest data on IQIRVO® (elafibranor) demonstrating clinically meaningful improvements in ALP, a surrogate marker of primary biliary cholangitis (PBC) disease progression, and symptom management, achieved in a real-world setting, will be presented at the European Association for the Study of Liver Disease (EASL) 2026 congress in Barcelona. IQIRVO is the only PBC therapy with data on meaningful improvements on Alkaline Phosphatase (ALP) reduction and both fatigue and pruritus symptoms.
In a late-breaking presentation, the depth of effect of IQIRVO on ALP normalization in PBC patients with ALP 1-1.67 x upper limit of normal (ULN) in the real-world setting will be presented. Normalization of ALP levels (<1 x ULN) is associated with improved prognosis and increased survival rates. Ipsen is currently conducting a Phase III study, ELSPIRE, which is evaluating IQIRVO in this patient population, in a clinical setting.
Additionally, Ipsen will present interim real-world data from the ELFINITY® Phase IV study confirming real-world effectiveness of IQIRVO in both biochemical outcomes and symptom control, including fatigue and pruritus, with a favorable safety profile.
Further late-breaking data includes a new post-hoc analysis from the Phase III pivotal ELATIVE® trial, which will provide further evidence of the impact of IQIRVO on fatigue, using the established Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a (PROMIS PFSF 7a) tool. Fatigue is the most common and debilitating symptom reported by PBC patients. IQIRVO is the only medicine to have demonstrated a positive effect on fatigue in patients with moderate to severe fatigue at baseline and occurring independently of its effect on pruritus.1
With two molecules approved for three different rare cholestatic liver diseases and a pipeline with two additional late-stage indications, Ipsen is leading research and development for treatments where unmet need is high and treatments are often few or do not exist.
Additional information on https://www.ipsen.com/press-release/late-breaking-data-from-easl-reinforces-iqirvos-impact-on-alp-reduction-with-fatigue-and-pruritus-improvement-in-patients-with-pbc-3295548/