Ocaliva fails NASH trial just as Intercept charts path toward FDA application

The path to a potential nonalcoholic steatohepatitis (NASH) drug approval just got bumpier for Intercept Pharmaceuticals.

The company’s obeticholic acid (OCA) has failed to top placebo at improving liver scarring among patients with compensated NASH-related cirrhosis in a phase 3 trial, Intercept said Friday. The drug is currently marketed as a biliary cirrhosis treatment under the brand name Ocaliva.

Ref: https://www.fiercepharma.com/pharma/ocalivas-2nd-nash-trial-bites-dust-just-intercept-charts-path-fda-re-application