The U.S. Food and Drug Administration (USFDA) on Tuesday has granted accelerated approval to French drugmakers Ipsen and Genfit’s drug to treat chronic inflammatory liver disease.
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.
According to a report news agency Reuters, standard approval for the drug Iqirvo may be contingent on confirmatory trials.
Intercept Pharmaceuticals’ drug obeticholic acid, branded as Ocaliva, is currently approved for PBC patients in combination with ursodeoxycholic acid (UDCA), or as a single therapy in patients unable to tolerate UDCA.
Based on this approval, the Genfit-Ipsen drug is also to be used with UDCA or as a monotherapy in those who are unable to tolerate UDCA.
Iqirvo’s approval was based on data from a 161-patient late-stage trial in which it significantly reduced levels of an enzyme called alkaline phosphatase that can lead to liver damage at high levels.
(With inputs from Reuters)