2 Information about elafibranor

Marketing authorisation indication

2.1

Elafibranor (Iqirvo, Ipsen) 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'.

Dosage in the marketing authorisation

Price

2.3

The list price of elafibranor is £2,867 for a 30‑tablet pack of 80 mg tablets (excluding VAT; company submission).

2.4

The company has a commercial arrangement. This makes elafibranor available to the NHS with a discount. The size of the discount is commercial in confidence.