(Reuters) – The U.S. Food and Drug Administration on Thursday declined to grant accelerated approval for Intercept Pharmaceuticals’ drug to treat a type of fatty liver disease.
The rejection marks Intercept’s second failed attempt at securing approval for the drug to treat patients with non-alcoholic steatohepatitis (NASH) – a liver disease that affects 5% of U.S. adults but has no approved treatments after numerous clinical failures by several drugmakers.
Following the decision, the company said it has decided to discontinue all NASH-related investment and restructure its operations to strengthen focus on rare and serious liver diseases.
The FDA’s decision was on expected lines. In May, its panel of advisers recommended holding off on accelerated approval for the oral drug till its late-stage study data becomes available.
Intercept CEO Jerry Durso said last month a rejection would lead the company to turn its focus and work towards becoming profitable.
(Reporting by Sriparna Roy, Leroy Leo, Raghav Mahobe and Granth Vanaik in Bengaluru; Editing by Devika Syamnath and Krishna Chandra Eluri)
