What is it prescribed for?
Iqirvo, Approved on June 10, 2024, is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
What is the name of the drug and what does it do?
Iqirvo (pronounced eye-KER-vo), (generic name: elafibranor), is a medication indicated for the treatment of primary biliary cholangitis (PBC) in adults.
It is used in combination with ursodeoxycholic acid (UDCA) in patients who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
How does it work?
Iqirvo is a peroxisome proliferator-activated receptor (PPAR) agonist.
PPARs are nuclear receptors that regulate gene expression involved in lipid metabolism and inflammation.
By activating PPAR-alpha, PPAR-gamma, and PPAR-delta, Iqirvo helps reduce bile acid synthesis and inflammation, improving liver function and reducing the symptoms of PBC.
What did the research discover?
Clinical trials demonstrated that Iqirvo significantly reduces alkaline phosphatase (ALP) levels, a marker of liver damage, in patients with PBC.
In Study 1, patients treated with Iqirvo showed greater improvement in biochemical response rates and ALP normalization compared to those treated with a placebo.
The study confirmed that Iqirvo helps manage the disease more effectively in patients who do not respond adequately to UDCA.
What are some of the side effects?
- Weight gain
- Diarrhea
- Abdominal pain
- Nausea
- Vomiting
- Arthralgia (joint pain)
- Constipation
- Muscle pain
- Fractures
- Gastroesophageal reflux disease (GERD)
- Dry mouth
- Weight loss
- Rash
What are the dosage recommendations and how is it prescribed?
Iqirvo is prescribed as an oral tablet with the recommended dosage being 80 mg taken once daily, with or without food.
It is important to evaluate for muscle pain or myopathy before initiating treatment and to monitor for any signs of liver injury or hypersensitivity reactions.
Adjustments may be needed for patients taking bile acid sequestrants or those who experience significant side effects.
Source:
- Ipsen Biopharmaceuticals, Inc. Iqirvo (elafibranor) tablets, for oral use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218860s000lbl.pdf
