US FDA decision imminent on Intercept's Ocaliva for liver disease

US biopharma Intercept Pharmaceuticals (Nasdaq: ICPT) is due to find out on Friday whether its liver disease drug Ocaliva (obeticholic acid) receives approval from the Food and Drug Administration (FDA).

In early April, an FDA Advisory Committee unanimously recommended accelerated approval of the drug, which the regulator is not bound by but considers when making a decision.

If approved, Ocaliva would be the first new treatment for liver disease primary biliary cholangitis (PBC) in 20 years. It is largely a disease of women, afflicting approximately one in 1,000 women over the age of 40. Since 1988, PBC has been the second-leading overall cause of liver transplant in women in the USA, behind hepatitis C.