Intercept announced that the FDA has issued a Complete Response Letter in response to the company’s New Drug Application – NDA – for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis, or NASH. The FDA indicated in the CRL that it has completed its review of the NDA and determined that it cannot be approved in its present form. Based on the content of the CRL, any resubmission of an NDA for OCA in NASH would require, at a minimum, successful completion of the long-term outcomes phase of the REGENERATE study. As a result of the CRL, Intercept has decided to discontinue all NASH-related investment, restructure the company’s operations to strengthen its focus on rare and serious liver diseases, and drive an accelerated path to profitability beginning in 2024.
Published first on TheFly
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