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With Phase III NASH Endpoints In Place, Intercept May Reach Market By 2018

Although it is the first company to reach Phase III in non-alcoholic steatohepatitis, Intercept has a long road ahead with a 2,500-patient trial that will include a 72-week interim look that could lead to initial approval in the U.S. and EU.

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 (OCA) in NASH with an interim histological analysis that could lead to initial approval

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