Intercept Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Intercept's New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). FDA indicated that it considers this a complete, Class 2 resubmission and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023, for the NDA. The timeline for the review of the NDA by FDA remains subject to change.

The NDA is supported by a robust body of evidence from the OCA NASH clinical development program, including two positive, interim 18-month analyses from the pivotal Phase 3 REGENERATE study in patients with pre-cirrhotic liver fibrosis due to NASH. In these analyses, OCA 25 mg consistently demonstrated double the response rate of placebo in reduction in liver fibrosis stage without worsening of any of the three histologic components of NASH, an endpoint consistent with FDA's draft guidance. Further, a detailed assessment of 2,477 patients in REGENERATE, including nearly 1,000 patients on study drug for at least four years, provides a well-characterized safety profile that is monitorable and manageable, and supports chronic administration of OCA.