A panel of advisers to the U.S. Food and Drug Administration voted against approving Intercept Pharmaceuticals' (ICPT) investigational treatment for Nonalcoholic steatohepatitis, a serious progressive liver disease.
In Monday pre-market trade, ICPT was trading at $11.75 down $1.81 or 13.35%.
Nonalcoholic steatohepatitis (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. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH.
The company stated that twelve of 16 voting-eligible FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) members voted "no" (with two abstentions) on the voting 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."
Intercept said it continues to disagree with the FDA on certain characterizations of OCA's efficacy and safety in pre-cirrhotic fibrosis due to NASH and the role of non-invasive tests (NITs).
Advisory Committee votes, while not binding, are considered by the FDA when making its decision regarding the potential approval of a regulatory application. The FDA assigned a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 22, 2023.
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