12 out of 16 voting advisors voted “no” (with 2 abstentions) on the question: “Given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?”

15 out of 16 voting advisors vote to “defer approval pending submission and review of clinical outcome data from Study 747-303; at that point, the traditional route of admission could be considered.”

PDUFA target action date is June 22, 2023

The Company will host a conference call on Monday, May 22, 2023 at 8:30 a.m. ET

MORRISTOWN, NJ, May 19, 2023 (GLOBE NEWSWIRE) — Intercept Pharmaceuticals, Inc. ICPTa biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of progressive non-viral liver disease, today announced the results of the U.S. Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to review the Company’s New Drug Application (NDA) for Obeticholic Acid (OCA) for the Treatment of Precirrhotic Fibrosis Due to Nonalcoholic Steatohepatitis (NASH).

Twelve of 16 GIDAC voting members voted “no” (with two abstentions) to the poll question: “Given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?” ?” Fifteen out of 16 voting GIDAC members (no abstentions) voted to “defer approval pending submission and review of clinical outcome data from Study 747-303, at which time the traditional approval route could be considered.”

“We are disappointed with the outcome of today’s meeting,” said Jerry Durso, Intercept’s President and Chief Executive Officer. “We continue to disagree with the FDA on certain characterizations of the efficacy and safety of OCA in precirrhotic fibrosis due to NASH and the role of non-invasive tests (NITs), as discussed in today’s meeting. Intercept’s solid evidence was backed up by public statements from the liver…