FDA to convene AdCom on Intercept's NASH candidate

13 March 2023

Shares of US drug developer Intercept Pharmaceuticals (Nasdaq: ICPT) closed almost 14% lower at $16.12 on Friday, after it revealed that the US regulator will hold an advisory committee (AdCom) meeting to review its re-submitted approval request for its investigational non-alcoholic steatohepatitis (NASH) treatment obeticholic acid (OCA).

The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) will discuss Intercept’s new drug application (NDA) for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to NASH on May 19, 2023. The Advisory Committee Meeting will be hosted as a virtual meeting.

Recent setbacks

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