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# Reviewers Generally Favorable to Intercept NDA
- URL: https://www.fdaweb.com/reviewers-generally-favorable-to-intercept-nda/
- Published: 2016-04-05T12:00:00.000Z
- Updated: 2026-09-14T20:52:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135281

> FDA medical reviewers did not raise any serious issues about Intercept Pharmaceuticals’ NDA for obeticholic acid (OCA) for treating primary biliary cirrhosis in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable to tolerate it. The reviewers’ comments were in a [briefing document](http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm494107.htm?ref=fdaweb.com) released in advance of a 4/7 meeting of the Gastrointestinal Drug Advisory Committee that will consider the Intercept NDA.  
>  
> The document says that 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.  
>  
> The advisory committee will be asked to consider the company’s choice of the primary endpoint for its late-stage study and whether a different dosing regimen is required for more severely affected patients. Reviewers recommended a less frequent starting dose for patients with moderate to severe liver disease.  
>  
> Use of OCA has been associated with elevated lipid levels and increased instances of pruitis.