Intercept Pharmaceuticals said Monday that the Food and Drug Administration rejected its drug to treat the fatty liver disease known as NASH — a decision that has obvious negative consequences for Intercept but could also raise concerns for other drugmakers developing similar treatments.
According to a statement from Intercept, FDA officials determined the “predicted benefit” of the company’s drug called obeticholic acid, or OCA, “does not sufficiently outweigh the potential risks” to support approval as a treatment for patients with NASH. The FDA further recommended that Intercept submit additional efficacy and safety data from its Phase 3 clinical trial.
Shares of Intercept fell 37% To $49 in early Monday trading.
About the Author Reprints
The NASH companies that will benefit from this are the ones that have clinical outcomes for the endpoints. Not just some measure of histology under the microscope.