Full Data For Intercept's Liver Disease Drug Show Rivals Where To Differentiate

Despite Intercept Pharmaceuticals Inc. winning US FDA approval in May for its chronic liver disease therapy Ocaliva (obeticholic acid) – which became the first new drug for the treatment of rare liver disease primary biliary cholangitis (PBC) to reach the market in more than 20 years – full Phase III data published in the New England Journal of Medicine have highlighted some flaws in the study exposing potential gaps that could be filled by upcoming pipeline drugs.

On May 27, 2016 the FDA granted accelerated conditional approval for Intercept's Ocaliva for the treatment of PBC, a chronic disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed, in combination with Impax Laboratories Inc.'s ursodiol (ursodeoxycholic acid; UDCA) or as a monotherapy in adults unable to tolerate UDCA. Aside from Ocaliva, UDCA is the only other available drug for treatment of the disease, having been approved in 1997