Intercept Pharmaceuticals said Thursday that an extensive re-analysis of a large clinical trial involving its experimental treatment for the fatty liver disease known as NASH once again achieved its primary efficacy goal.
The company intends to use the new data to resubmit a marketing application in the U.S., although its approvability is likely to remain a hotly debated question.
The Food and Drug Administration rejected Intercept’s original marketing application for the NASH drug called obeticholic acid, or OCA, in June 2020. Regulators were concerned that the efficacy analyses read from liver biopsy slides by a single physician were too unreliable, particularly given the drug’s reported side effects.
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