Intercept Pharma (ICPT) Said Analyst Note Incorrect
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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) 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.
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