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Ipsen In Pole Position For Rare Liver Disease

 
• By Kevin Grogan

The FDA is set to make a decision on elafibranor for primary biliary cholangitis by June next year, which could give Ipsen a head start over CymaBay's seladelpar.

David Loew
David Loew • Source: Ipsen

Ipsen SA's ambitions to change the management of primary biliary cholangitis (PBC) are on track after the French drugmaker bagged a speedy review from US regulators for elafibranor.

The US Food and Drug Administration has granted a priority review for elafibranor, an oral, once-daily PPAR alpha/delta agonist which Ipsen believes could be the first novel second-line treatment for PBC, a rare cholestatic liver disease where bile ducts are gradually destroyed, in nearly a decade

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