Iqirvo (elafibranor) label update to reflect Phase 3 ELSPIRE data and add lower ALP patients (ALP >1 × ULN and <1.67 × ULN)

In its Q3 2026 earnings call, Ipsen indicated for Iqirvo (elafibranor, PPAR α/δ agonist):

• Regulatory submission of the Phase 3b ELSPIRE data is underway for a PBC label update (no specified the submission date, review designation or geographies). Management stated that the aim is to add ELSPIRE data to the label’s clinical trial section so that the field force can promote those data following their inclusion in the label.
  • The Phase 3b ELSPIRE trial assessed patients with ALP >1 × ULN and <1.67 × ULN.
  • it is expected the full data to be presented as a late-breaker at AASLD 2026, alongside IDEAL, and a potential FDA label update decision in Q2 2027.
• In the Q&A, Ipsen cited approximately 40,000 patients with ALP >1.67 × ULN and approximately 30,000 with ALP 1-1.67 × ULN, without specifying geographic scope. Management stated that approximately 20% of Iqirvo sales already come from the lower-ALP segment through spontaneous uptake. 
• Ipsen also reiterated PSC as a potential future opportunity for elafibranor, which remains in Phase 3 development through ELASCOPE.
  • Per Ipsen’s Q1 2026 commentary, a PSC launch would be under a separate brand name with ~7 years of orphan exclusivity (launch estimate: 2031).