Published on 22 May 2023 on Zacks via Yahoo Finance
Intercept Pharmaceuticals, Inc. ICPT announced that the FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting has voted against the approval of the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis (NASH).
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
Twelve of the sixteen voting-eligible advisors voted negative on 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 of 16 voting-eligible GIDAC members (with no abstentions) voted to “defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered.”