Drug updated on 12/11/2024
| Dosage Form | Tablet (Oral; 80 mg) |
| Drug Class | Peroxisome proliferator-activated receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Elafibranor combined with ursodeoxycholic acid (UDCA) was the most effective treatment in reducing alkaline phosphatase (ALP) levels in patients with primary biliary cholangitis (PBC) refractory to UDCA, showing a mean difference (MD) of 140.73 (95% confidence interval (CI): 74.34, 209.98). It had the highest likelihood (32%) of being the optimal regimen.
- Other drugs, including bezafibrate (MD 104.49, 95% CI: 60.41, 161.92), fenofibrate (MD 87.81, 95% CI: 52.34, 129.79), OCA (MD 65.21, 95% CI: 8.99, 121.80), seladelpar (MD 117.39, 95% CI: 19.97, 213.95), and saroglitazar (MD 132.09, 95% CI: 13.99, 247.04), also improved ALP levels but were less effective compared to elafibranor.
- The study focused on PBC patients refractory to UDCA without specifying additional subgroups such as age, gender, or comorbid conditions.
- There is no safety information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Iqirvo (elafibranor) Prescribing Information. | 2024 | Ipsen Biopharmaceuticals, Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Optimal drug regimens for improving ALP biochemical levels in patients with primary biliary cholangitis refractory to UDCA: a systematic review and Bayesian network meta-analysis | 2024 | BMC Systematic Reviews |