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IQIRVO® (elafibranor) therapeutic indication1

IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.1

IQIRVO ELATIVE trial

Safety data

IQIRVO safety data: a 2L treatment for PBC with a similar
percentage of adverse events vs placebo + UDCA1

Any AE attributed to the ELATIVE trial regimen that emerged during treatment period*1–3

  • Most AEs were mild to moderate1,2
  • Serious TEAEs were similar to placebo + UDCA (10% vs 13%, respectively)1
  • Discontinuation rate due to AEs was similar to placebo + UDCA (10% vs 9%, respectively)1
  • The most common AE leading to discontinuation was increased blood CPK (3.7%)2

Full safety information can be found in the SmPC.

Footnotes

*Included are any AEs occurring in >10% of patients in either treatment group in the ELATIVE trial, as well as those listed as common (≥1/100 >1/10) in the SMPC for completeness.1,2
Patients either received IQIRVO on a background of UDCA (102/108, 94%) or received UDCA plus a placebo (51/53, 96%).1

Abbreviations

AE, adverse event; CPK, creatine phosphokinase; TEAE, treatment-emergent adverse event; UDCA, ursodeoxycholic acid.

References

  1. Kowdley KV et al. N Engl J Med. 2024;390(9):795–805.
  2. IQIRVO® (elafibranor) Summary of product characteristics (SmPC). 2024.
  3. Kowdley KV et al. Supplement to: N Engl J Med. 2024;390(9):795–805.