Intercept wins EU approval for liver disease drug

USA-based Intercept Pharmaceuticals (Nasdaq: ICPT) has won conditional marketing authorization from the European Commission for its liver disease drug Ocaliva (obeticholic acid).

The drug, which treats the rare condition primary biliary cholangitis (PBC), an autoimmune disease of the liver that primarily affects women, has been approved in combination with ursodeoxycholic acid (UDCA) in adults with who do not adequately respond to UDCA, or as monotherapy in adults unable to tolerate UDCA.

The accelerated European approval follows that granted in the USA in May this year for Intercept’s lead drug candidate.