Ipsen’s Iqirvo approved in Europe

The European Commission has conditionally approved the marketing application submitted by Ipsen (Euronext: IPN) for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) – a rare liver disease - in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA.

The French drugmaker noted that Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist, that exerts an effect on the proteins PPARα and PPARδ, thought to be key regulators of bile acid, inflammation and fibrosis.

Iqirvo was licensed from fellow France-based Genfit (Euronext: GNFT), which recently – when the drug won US approval - said it anticipates receiving milestone payments from Ipsen totaling around 89 million euros ($97 million).Genfit’s shares rose more than 10% to 4.31 euros on Friday’s news, while Ipsen’s shares were barely changed.