▼ This medicinal product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on 01753 627777.
UNLOCK THE IQIRVO®▼ (ELAFIBRANOR) EFFECT
A once-daily tablet for all eligible patients – with no dose adjustment required1
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
This medicinal product has been authorised in Northern Ireland under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited.
IQIRVO
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Footnotes
*Cholestasis response is defined in the trial as ALP <1.67 x ULN, and ALP decrease ≥15% and TB ≤ULN at 52 weeks.5
†Patients either received IQIRVO on a background of UDCA (102/108) or received UDCA plus a placebo (51/53).5
‡IQIRVO + UDCA met the primary endpoint of cholestasis response, defined as by ALP <1.67 x ULN, and ALP decrease ≥15% and TB ≤ULN. Reduction in ALP and bilirubin is predictive of long-term outcomes.1,6–9
Abbreviations
ALP, alkaline phosphate; PBC, primary biliary cholangitis; PPAR, peroxisome proliferator-activated receptor ; TB, total bilirubin; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.
References
- IQIRVO® (elafibranor) Summary of product characteristics (SmPC). 2024.
- Trivedi HD et al. Frontline Gastroenterol. 2017;8(1):29–36.
- Invernizzi P et al. Dig Liver Dis. 2017;49(8):841–846.
- Hirschfield GM et al. Expert Rev Gastroenterol Hepatol. 2021;15(8):929–939.
- Kowdley KV et al. N Engl J Med. 2024;390(9):795–805
- Lammers WJ et al. Gastroenterology. 2014;147(6):1338–1349.
- Corpechot C et al. Clin Res Hepatol Gastroenterol. 2022;46(1):101770.
- de Veer RC et al. Aliment Pharmacol Ther. 2022;56(9):1408–1418.
- Murillo Perez CF et al. Am J Gastroenterol. 2020;115(7):1066–1074.