Intercept provides regulatory update
Last Modified: 03:29 PM, Mon May 25, 2020
ENP Newswire. 25 May 2020

Word Count: 458

Release date - 22052020

NEW YORK - Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that based on discussions earlier this week, the U.S. Food and Drug Administration (FDA) has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company's new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed.

The postponement will accommodate the review of additional data requested by the FDA that the company intends to submit within the next week. The FDA has indicated that it will reach out to Intercept in the near future with a new proposed AdCom date. Intercept now anticipates that the FDA's review of its NDA will extend beyond the Prescription Drug User Fee Act (PDUFA) target action date of June 26, 2020.

'While this delay was unanticipated, following our most recent dialogue with the FDA we believe that the additional data being submitted will be important in facilitating a more informed discussion at the AdCom,' said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. 'We remain confident in our NDA submission and look forward to continuing to work with the FDA to bring the first treatment to patients with advanced fibrosis due to NASH.'

Intercept previously announced the FDA's acceptance of the NDA and granting of priority review. OCA has received Breakthrough Therapy designation from the FDA for the treatment of NASH patients with liver fibrosis.

About Liver Fibrosis due to NASH

Nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH. In the United States, NASH is currently the second leading cause for liver transplantation overall, and in females, the leading cause. NASH is anticipated to become the leading indication for liver transplantation in Europe within the next decade. There are currently no medications approved for the treatment of NASH.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada.

Contact:

Lisa DeFrancesco Tel: +1-646-565-4833 Email: investors@interceptpharma.com

[Editorial queries for this story should be sent to newswire@enpublishing.co.uk]

Powered by InfoDesk
RIS
InfoDesk Inc
Article Info
Publication: ENP Newswire
Organization: Intercept Pharmaceuticals, Inc., U.S. Food and Drug Administration
Location: United States
Industry: Pharmaceuticals, Health Care/Life Sciences, Biotechnology, Biopharmaceuticals
Topics
New Products/Services, Regulation/Government Policy, Corporate/Industrial News, Products/Services