US FDA grants accelerated approval to Genfit and Ipsen's liver disease drug (updated)

Ipsen SA

10/06/2024 22:14

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       June 10 (Reuters) - The U.S. Food and Drug
Administration has granted accelerated approval French
drugmakers Ipsen  IPN.PA  and Genfit's  GNFT.PA  drug to treat a
chronic inflammatory liver disease, Ipsen said on Monday.
    Primary biliary cholangitis (PBC) causes inflammation of the
small bile ducts in the liver and eventually destroys them. The
disease, which primarily affects women aged 30 to 60, impacts
75,000 in the United States.  
        Iqirvo, chemically known as elafibranor, is an oral,
once-daily drug for PBC. 
  
        Standard approval for the drug may be contingent on
confirmatory trials.
  

 (Reporting by Puyaan Singh in Bengaluru; Editing by Alan
Barona)
 ((Puyaan.Singh@thomsonreuters.com;))