Intercept to Resubmit NDA to FDA With New Phase 3 Data

Intercept Pharmaceuticals will resubmit a New Drug Application (NDA) for its investigational drug obeticholic acid (OCA) for treatment of patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease.

In June 2020, the FDA rejected the company’s NDA in a Complete Response Letter, noting that the submitted data did not clearly show the drug’s benefit.

The company now has a new analysis of data from a phase 3 study showing that the oral OCA treatment led to 22.4 percent of participants achieving an improvement in liver fibrosis with no worsening of NASH at month 18, compared with 9.6 percent of those taking placebo.

Intercept has a pre-submission meeting with the agency scheduled this month.