Intercept to resubmit NASH treatment application for FDA review
July 7 (Reuters) – Intercept Pharmaceuticals (ICPT.O) said on Thursday it would resubmit its application for nonalcoholic steatohepatitis (NASH) treatment to the U.S. Food and Drug Administration based on new interim analysis of data from an ongoing late-stage study.
The company is seeking approval for obeticholic acid to treat fibrosis or scarring associated with NASH, a serious progressive liver disease caused by excessive fat accumulation in the liver.
The agency declined to approve obeticholic acid in 2020 saying the “predicted benefit remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval”.
At the time, the FDA recommended Intercept submit additional data from the late-stage study.
The company said new interim analysis shows 22.4% of subjects achieved the main goal of improvement in at least one stage of fibrosis with no worsening of NASH at month 18 compared with 9.6% of subjects on placebo.
“The weight of evidence in both safety and efficacy has notably increased and provides a more robust benefit:risk profile,” Chief Executive Officer Jerry Durso said.
Intercept will meet with the FDA to discuss its application later this month.
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