With a CHMP positive opinion in the bag, liver disease focused Intercept Pharmaceuticals Inc. is gearing up for a European approval for its FXR (farnesoid X receptor) agonist, Ocaliva (obeticholic acid). Following the lead of the US FDA, the European Medicines Agency’s CHMP (Committee for Medicinal Products for Human Use) has recommended conditional approval for the drug in treating primary biliary cholangitis (PBC), an autoimmune cholestatic liver disease, for which currently there is only one approved medication in Europe, ursodeoxycholic acid (UDCA). Not all patients tolerate or respond sufficiently to UDCA, and they can go on to develop cirrhosis and liver failure leading to liver transplant or death.
A CHMP positive opinion usually leads to European approval within 2-3 months, and this is expected by the end of...
