IPSEY - FDA Fast-Tracks Ipsen And Genfit's New Liver Disease Treatment Iqirvo | Benzinga
Ipsen SA (OTC:IPSEF) (OTC:IPSEY) announced Monday that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets to treat primary biliary cholangitis (PBC).
PBC is a rare, autoimmune, cholestatic liver disease where a build-up of bile and toxins and chronic inflammation causes irreversible fibrosis of the liver and destruction of the bile ducts.
This drug is approved for use with ursodeoxycholic acid (UDCA) or as a standalone treatment in cases where UDCA is not tolerated.
Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed from GENFIT S.A. (NASDAQ:GNFT) in ...