Intercept’s Early NASH Efforts Will Stress Advanced Fibrosis

Intercept Pharmaceuticals Inc. believes it has identified the sweet spot for its initial marketing focus in non-alcoholic steatohepatitis (NASH) as patients with advanced fibrosis, and that the specialist physicians who will be its target customers are on board. Further, the firm said early talks with payers indicate they agree that treating NASH patients with advanced fibrosis and trying to avoid progression to cirrhosis is a sensible strategy both medically and economically.

Intercept outlined its commercial strategy during an investor presentation on 16 December, just after revealing that the US Food and Drug Administration has scheduled an advisory committee to review the new drug application for obeticholic acid (OCA) to treat NASH patients with fibrosis and that the user fee date would be extended from the original 26 March deadline