Intercept Company Statement on Analyst Note

NEW YORK, Jan. 27, 2021 (GLOBE NEWSWIRE) — 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 an analyst note commenting on the listing of Intercept’s product on the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) website reached a conclusion regarding the status of a newly identified safety signal (NISS) for Ocaliva^® (obeticholic acid) that the Company believes is incorrect.
The FDA provides quarterly information on newly identified safety signals. The Company does not believe that the absence of a listed medicine that was in one quarterly update in a subsequent quarter necessarily indicates that the FDA has completed its evaluation of the NISS.As Intercept has previously communicated, the Company has submitted a comprehensive safety assessment to the FDA and the dialogue with the FDA regarding the Agency’s evaluation of the NISS for Ocaliva remains ongoing.As the Company has also previously stated, the FDA notified Intercept in May 2020 that, in the course of its routine safety surveillance of postmarketing data, the FDA began to evaluate a NISS regarding liver disorder for Ocaliva which the FDA classified as a potential risk, the lowest level of risk. Pursuant to the FDA’s guidance, this does not mean that the FDA has concluded that the drug has the listed risk or that the FDA has identified a causal relationship between Ocaliva and the potential risk. The FDA has informed the Company that the FDA’s review of the NISS is focused on a subset of the cirrhotic, or more advanced, PBC patients who have taken Ocaliva.About InterceptIntercept 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. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.Cautionary Note Regarding Forward-Looking StatementsCONTACTFor more information about Intercept, please contact: For investors:
investors@interceptpharma.com For media:
media@interceptpharma.comSource: Intercept Pharmaceuticals, Inc.