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Ocaliva Exit Could Help Ipsen And Gilead’s New Cholangitis Entrants

 
• By Andrew McConaghie

The FXR agonist drug is facing market removal in the EU and possibly the US, which could open the door for two new PPAR agonist therapies.

Gilead
Gilead and Ipsen/Genfit's products could benefit from an EU withdrawal of the drug. • Source: Shutterstock

The omens for Advanz Pharma and Intercept’s primary biliary cholangitis treatment, Ocaliva, are not looking good on either side of the Atlantic.

The daily oral treatment is currently licensed for the second-line treatment of the rare autoimmune liver disease, but the European Medicines Agency wants to remove it from the market due to lack of efficacy data, while a US Food and Drug

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