Intercept: Surrogate endpoint not enough for FDA to approve NASH therapy

Intercept believes FDA’s “evolving” thinking on efficacy endpoints for NASH therapies led to the complete response letter for Ocaliva that destroyed about two-fifths of the company’s market value on Monday.

The company said FDA declined to approve Ocaliva obeticholic acid to treat fibrosis due to non-alcoholic steatohepatitis, citing a risk-benefit profile that remains uncertain based on a surrogate efficacy endpoint. Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said FDA requested additional post-interim data from the Phase III REGENERATE study of the FXR inhibitor, and said the company should continue the trial’s long-term outcomes phase...