Finalization of Phase III endpoints for non-alcoholic steatohepatitis (NASH) has been eagerly anticipated, but now that Intercept Pharmaceuticals Inc. has outlined a potential pathway to approval in this unmet medical need, it faces a long road before perhaps reaching market in late 2018 at the earliest.
In consultation with both FDA and the European Medicines Agency, Intercept agreed to a single, 2,500-patient trial for obeticholic acid...