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# FDA Panel Unanimously Backs Intercept’s Obeticholic Acid NDA
- URL: https://www.fdaweb.com/fda-panel-unanimously-backs-intercepts-obeticholic-acid-nda/
- Published: 2016-04-08T12:00:00.000Z
- Updated: 2026-09-14T20:53:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135312

> FDA’s Gastrointestinal Drug Advisory Committee has unanimously (17 to 0) voted to recommend approval for an Intercept Pharmaceuticals NDA for obeticholic acid (OCA) for treating primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable to tolerate it. In an FDA [briefing document](http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm494107.htm?ref=fdaweb.com), CDER medical reviewers did not raise any serious issues about the submission. The user fee target date for a review action is 5/29\. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.  
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> The panel’s recommendation is based on data from the Phase 3 POISE trial, which assessed OCA’s safety and efficacy in 216 PBC patients who had an inadequate therapeutic response to, or were unable to tolerate, ursodeoxycholic acid. OCA is manufactured as 5 mg and 10 mg tablets to be administered orally once daily. The company proposes a dosing regimen starting with a dose of 5 mg daily for the first three months followed by titration up to 10 mg daily based on tolerance to the medication and biochemical response. It says that OCA is a new molecular entity that has not been approved for any other indication.