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Elafibranor (Iqirvo°) in primary biliary cholangitis

 Marketing Authorisations  Elafibranor has been authorised in the European Union for use in patients with primary biliary cholangitis, either as monotherapy or in combination with ursodeoxycholic acid. Does elafibranor reduce mortality when added to ursodeoxycholic acid in patients with primary biliary cholangitis in whom ursodeoxycholic acid is considered insufficiently effective, or as monotherapy when ursodeoxycholic acid causes unacceptable adverse effects? Does it alleviate symptoms and reduce the incidence of complications? And what are its adverse effects?
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EDITORS' OPINION
Haste

In the European Union, a drug that has undergone insufficient evaluation can be granted "conditional" marketing authorisation, with the objective of hastening access to the drug. In order to convert a conditional marketing authorisation into a full standard marketing authorisation, the pharmaceutical company concerned is required to continue the evaluation or conduct additional trials...

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 ©Prescrire 1 July 2026

Source: "Elafibranor (Iqirvo°) in primary biliary cholangitis" Prescrire Int 2026; 35 (283): 173-175. Subscribers only.

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See also:
 
"Obeticholic acid and
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Severe adverse effects
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