US FDA grants accelerated approval to Genfit and Ipsen’s liver disease drug

(Reuters) -The U.S. Food and Drug Administration has granted accelerated approval French drugmakers Ipsen and Genfit’s 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)