Ipsen presents long-term elafibranor efficacy and itch-related quality of life data in patients with primary biliary cholangitis    

  • New data from the ELATIVE® Phase III trial show 70% of patients treated with elafibranor achieved composite endpoint of slowing disease progression measured by biochemical response after 78-weeks
  • Data from the itch domain of the PBC-40 and 5-D Itch questionnaires shows the potential of elafibranor to improve itch-related quality of life in patients with moderate-to-severe pruritus
  • Significant unmet need remains for new treatment options in primary biliary cholangitis that control disease progression and debilitating symptoms impacting quality of life

PARIS, FRANCE, DD June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced new late-breaking data at the European Association for the Study of the Liver (EASL) Congress demonstrating the enduring efficacy of elafibranor in managing disease progression after 78 weeks of treatment. In the variable double-blind period of the ELATIVE® Phase III trial in primary biliary cholangitis (PBC), the potential for elafibranor to improve itch-related quality of life (QoL) as measured by the itch domain of the PBC-40 and the 5-D Itch questionnaire was also demonstrated. Elafibranor is a novel, potential first-in-class, PPAR agonist. It is currently under review by the U.S. Food and Drug Administration, the European Medicines Agency and the UK Medicines and Healthcare Products Regulatory Authority.

“There are a significant proportion of people living with PBC who experience worsening disease and debilitating symptoms despite being on treatment. These long-term data from the Phase III ELATIVE study further demonstrate the potential for elafibranor to provide an effective treatment option for these patients,” said Sandra Silvestri, M.D. Executive Vice President and Chief Medical Officer, Ipsen. “A lack of effective management can lead to advanced forms of the disease where liver transplantation may be the only option. Transplants are not trivial, so we must and can do better to preserve native liver function for people living with PBC.”

Data presented at EASL for patients who had their week-78 double-blind visit (30 patients receiving elafibranor and 13 patients receiving placebo) demonstrated the efficacy of elafibranor was sustained after 78 weeks of treatment with 70% of patients on elafibranor meeting the composite endpoint of biochemical response versus 0% on placebo. Biochemical response was defined as alkaline phosphatase (ALP)

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