Primary biliary cholangitis

Active Ingredient: Elafibranor

Indication for Elafibranor

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Elafibranor 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 patients unable to tolerate UDCA.

For this indication, competent medicine agencies globally authorize below treatments:

80 mg once daily

For:

Dosage regimens

Oral, 80 milligrams elafibranor, once daily.

Detailed description

The recommended dose is 80 mg once daily.

Missed dose

If a dose of elafibranor is missed, the patient should not take the missed dose and instead take their subsequent dose at the next scheduled time point. The patient should not take a double dose to make up for the missed dose.

Active ingredient

Elafibranor

Elafibranor and its main active metabolite GFT1007 are dual peroxisome proliferator-activated receptor (PPAR)α/δ agonists. PPAR α/δ are thought to be key regulators of bile acid (BA) homeostasis, inflammation and fibrosis. Activation of PPARα and PPARδ decreases bile toxicity and improve cholestasis by modulating BA synthesis, detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways.

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