Following new data, Intercept to re-file NDA for obeticholic acid
US biopharma company Intercept Pharmaceuticals (Nasdaq: ICPT) yesterday announced positive top-line results from a new interim analysis of its ongoing pivotal Phase III REGENERATE trial of obeticholic acid (OCA) in patients with liver fibrosis due to non-alcoholic steatohepatitis (NASH).
This is the second analysis in which OCA has met the primary endpoint for the intent-to-treat (ITT) population in REGENERATE and based on these results, Intercept will be re-submitting its new drug application (NDA) for OCA in liver fibrosis due to NASH.
In June 2020, the company revealed the it had received a complete response letter from the Food and Drug Administration (FDA) regarding its NDA for obeticholic acid for the treatment of fibrosis due to NASH.
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