The agency’s briefing documents highlighted increased risk of diabetes and liver injury from using the obeticholic acid oral tablets for treatment of nonalcoholic steatohepatitis.
Tag Archive for: NASH treatment
Intercept Pharmaceuticals said 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.
