IQIRVO

What it is

IQIRVO contains 80 mg of elafibranor as the active ingredient. IQIRVO 80 mg film-coated tablets are round, orange, debossed with 'ELA 80' on one side. Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists, both of which activate PPARα, PPARγ, and PPARδ in vitro.

Approved indications

— Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA . — Treatment of primary biliary cholangitis (PBC) as monotherapy in adults unable to tolerate UDCA .

Dosing overview

The recommended dose is 80 mg once daily with or without food. No dose adjustment is necessary in patients older than 65 years of age. No dose adjustment is necessary in patients with renal impairment. No dose adjustment is necessary in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Use in patients with severe hepatic impairment (Child-Pugh C) is not recommended.

Key safety warnings

Increases in liver biochemical tests including transaminases and bilirubin increase have been reported in 3.7% of participants receiving elafibranor compared to 5.7% of participants receiving placebo. Clinical and laboratory assessment of liver function should be done prior to initiation of elafibranor treatment and thereafter according to routine patient management. Increases in blood creatine phosphokinase (CPK) have been reported in participants receiving elafibranor (3.7% in elafibranor group compared to 0% in placebo group). In addition to these reported CPK increases, there was one case of rhabdomyolysis which occurred in the pivotal phase 3 ELATIVE study in a participant with cirrhosis and ongoing treatment with an HMG-CoA reductase inhibitor. Periodic CPK measurements may be considered in patients starting elafibranor treatment, especially those on concomitant HMG-CoA reductase inhibitors. Patients on elafibranor treatment should be advised to report any unexplained muscle symptoms such as pain, soreness, or weakness to their treating physician. Based on data from animal studies, elafibranor may cause foetal harm when administered to a pregnant woman. Patients should be informed of the potential risk to the foetus if elafibranor is taken during pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment and for 3 weeks following the final dose of elafibranor. Elafibranor is not recommended during breastfeeding and for at least 3 weeks following last dose of elafibranor because the risk to breastfed child cannot be excluded.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

The 80 mg tablet strength is listed on the PBS with 3 items. The listing requires authority required or streamlined approval. The ex-manufacturer price is A$5722.20.

Regulatory history

The TGA approved IQIRVO (elafibranor) for the treatment of primary biliary cholangitis (PBC) in adults. The decision was made on 18 March 2025, with registration in the ARTG completed on 25 March 2025. In March 2025, the PBAC recommended IQIRVO for primary biliary cholangitis (PBC).