Given its setbacks this past year in non-alcoholic steatohepatitis, Intercept Pharmaceuticals, Inc.’s sales performance with primary biliary cholangitis drug Ocaliva (obeticholic acid/OCA) has gained importance. A US Food and Drug Administration labeling update on 26 May contraindicating the drug in PBC patients with advanced cirrhosis may dampen those revenue prospects while opening a market opportunity for a pair of Phase III candidates being studied by competitors as second-line PBC therapies.
Intercept also is developing OCA, an FXR agonist, as a potential treatment for NASH; the company received a complete response letter last June and is still working on refiling its new drug application with a goal of completing the resubmission this year. (Also see "S&E Briefs: The Good and The Bad Of COVID-19 On Biotech's Top Line" - Scrip, 6 May, 2021