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

Read the full 502 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE