FDA needs more time to decide on Intercept’s Ocaliva

The rocky road goes on for Intercept Pharmaceuticals with its primary biliary cholangitis (PBC) candidate Ocaliva (obeticholic acid).

Intercept - which is now a subsidiary of privately-held Italian pharma company Alfasigma - has been told by the US Food and Drug Administration (FDA) that the agency is continuing its review of the supplemental New Drug Application (sNDA) for full approval of Ocaliva in PBC.

Therefore, the FDA’s action under the Prescription Drug User Fee Act (PDUFA), previously expected on October 15, has been delayed. The FDA did not provide a new anticipated action date.