US FDA declines to approve Intercept's fatty liver disease drug (updated)

Intercept Pharmaceuticals

22/06/2023 22:56

(Adds background in paragraphs 2, 4 and 5, details from release
in paragraph 3)
       June 22 (Reuters) - The U.S. Food and Drug
Administration on Thursday declined to grant accelerated
approval for Intercept Pharmaceuticals'  ICPT.O  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)
 ((Sriparna.Roy@thomsonreuters.com;))