Posted by Michael Wonder on 29 Jun 2020
Intercept receives complete response letter from FDA for obeticholic acid for the treatment of fibrosis due to NASH
29 June 2020 - Intercept Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the new drug application for obeticholic acid for the treatment of fibrosis due to non-alcoholic steatohepatitis.
The letter indicated that, based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of obeticholic acid based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to non-alcoholic steatohepatitis.
