Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

Shots:Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoingTrial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectivelyElafibranor…

ByRidhi RastogiApril 24, 2025

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Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC)

Shots: The CHMP’s positive opinion of Iqirvo (PPAR agonist) + ursodeoxycholic acid (UDCA) for PBC adults having inadequate UDCA response or Iqirvo alone for UDCA intolerant patients was based on P-III (ELATIVE) study. EC’s decision is anticipated in Q3’24. The company has submitted Iqirvo for PBC to the MHRA The P-III (ELATIVE) study assessed Iqirvo…

ByDipanshu DixitJuly 26, 2024

Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC)

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Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC)

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