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Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH
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May 19, 2023
12 of 16 voting-eligible advisors vote "no" (with two abstentions) on question, "given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?"
15 of 16 voting-eligible advisors vote to "defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered"
PDUFA Target Action Date set for June 22, 2023
Company to host conference call on Monday, May 22, 2023, at 8:30 a.m. ET
MORRISTOWN, N.J., May 19, 2023 (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 the outcome of the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting to review the Company's New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
Twelve of 16 voting-eligible GIDAC members voted "no" (with two abstentions) on the voting question, "given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?" Fifteen of 16 voting-eligible GIDAC members (with no abstentions) voted to "defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered."
"We are disappointed in the outcome of today's meeting," said Jerry Durso, President and Chief Executive Officer of Intercept. "We continue to disagree with the FDA on certain characterizations of OCA's efficacy and safety in pre-cirrhotic fibrosis due to NASH and the role of non-invasive tests (NITs), as discussed in today's meeting. The robust body of evidence provided by Intercept was underscored by public testimony from the liver community, who supported OCA as an option to address the urgent treatment need in NASH and the use of NITs to manage this devastating disease in clinical practice."
Advisory Committee votes, while not binding, are considered by the FDA when making its decision regarding the potential approval of a regulatory application. As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 22, 2023. The timeline for review of the NDA by the FDA remains subject to change.
Conference Call on Monday, May 22, 2023, at 8:30 a.m. ET
The Company will host a conference call on Monday, May 22, 2023, from 8:30 – 9:00 a.m. ET to discuss the Advisory Committee Meeting. The conference call will be available via a listen-only webcast on the investor page of the company's website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. A replay of the call will be available on the Intercept website shortly following the completion of the call and will be available for one year.
https://ir.interceptpharma.com/news-releases/news-release-details/intercept-announces-outcome-fda-advisory-committee-meeting
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-panel-votes-against-accelerated-approval-intercept-fatty-liver-drug-2023-05-19/
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