Intercept Faces Uphill Battle for Impending FDA Adcom; Briefing Documents Released

Briefing documents have been posted (view here) for FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to discuss the use of Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to NASH. For context, the OCA adcom is on Friday, May 19, 2023 (previous FENIX insight). Recall, in January 2023, FDA accepted the NDA for OCA seeking accelerated approval as a Class 2 resubmission and assigned a PDUFA date of June 22, 2023 (previous FENIX insight). Of note, Intercept’s stock price decreased as much as -22% in intraday trading following the release of the briefing documents. Below, FENIX provides insight into the potential outcome of the OCA FDA adcom.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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