Intercept withdraws Ocaliva for PBC from the US market

Intercept Pharmaceuticals, a wholly-owned biopharmaceutical subsidiary of Italy’s privately-held Alfasigma, has announced its decision to voluntarily withdraw Ocaliva (obeticholic acid) from the US market for the treatment of primary biliary cholangitis (PBC), a rare, progressive liver disease.

This decision follows a request from the US Food and Drug Administration (FDA). In addition, the FDA has placed a clinical hold on all Intercept clinical trials conducted under a US investigational new drug (IND) involving obeticholic acid.