Intercept Pharmaceuticals announced Thursday that it will resubmit its application for non-alcoholic steatohepatitis (NASH) treatment to the US Food and Drug Administration based on a new interim analysis of data from ongoing late-stage studies.
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.
Authorities declined to approve obeticholic acid in 2020, stating that "expected benefits are still uncertain and do not well exceed the potential risks of supporting expedited approval." rice field.
At that time, the FDA recommended that Intercept submit additional data from late-stage trials.
According to the company, in a new interim analysis, 22.4% of subjects had at least one fibrosis without exacerbating NASH at 18 months, compared to 9.6% of placebo subjects. It is shown that the main goal of improvement has been achieved in stages.
"The weight of evidence in both safety and effectiveness has increased significantly, and a stronger advantage: it provides a risk profile," said CEO Jerry Dheso.
Intercept will meet with the FDA to discuss its application later this month.
(Report by Mrinalika Roy in Bangalore, edited by Vinay Dwivedi and Krishna Chandra Eluri)