The US Food and Drug Administration (FDA) has rejected Intercept Pharmaceutical’s second bid for approval of obeticholic acid (OCA) for treatment of nonalcoholic steatohepatitis (NASH) with stage 2 or 3 fibrosis.
In response, the company has decided to discontinue all NASH-related investment.
Intercept first sought FDA approval for OCA in treatment of NASH in 2019 and received a complete response letter. The company refiled for a new drug application this past December. A second resubmission would require a completion of the long-term outcomes phase of an ongoing clinical trial, according to an Intercept press release.