Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC)
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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
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The P-III (ELATIVE) study assessed Iqirvo (80mg, QD) vs PBO to treat PBC patients (n=161) having inadequate response or intolerance to UDCA
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Study reached the composite 1EP of BCR, showing 47% treatment benefit in 51% vs 4% of them at wk.52 with an ALP reduction of 41% in 15% vs 0% of them at wk.4 that was sustained till wk.52
Ref: Ipsen | Image: Ipsen
Related News:- Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis
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