Posted by Michael Wonder on 23 Jun 2023
Intercept receives complete response letter from FDA for obeticholic acid as a treatment for pre-cirrhotic fibrosis due to NASH
22 June 2023 - Company to discontinue all NASH-related investment and restructure the Company’s operations to strengthen its focus on rare and serious liver diseases.
Intercept Pharmaceuticals today announced that the US FDA has issued a complete response letter in response to the Company’s new drug application for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis.
