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# FDA Rejects Intercept’s NASH Drug
- URL: https://www.fdaweb.com/fda-rejects-intercepts-nash-drug/
- Published: 2020-07-06T12:00:00.000Z
- Updated: 2026-09-14T16:20:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147117

FDA has rejected Intercept Pharmaceuticals’ obeticholic acid for treating NASH (nonalcoholic steatohepatitis). *Endpoint News* [reports](https://endpts.com/fda-rejects-intercepts-pitch-for-nash-as-execs-fire-back-at-the-agencys-evolving-guidelines/?ref=fdaweb.com) that FDA postponed two advisory committee meetings that were to consider the company’s NDA and then rejected the drug because agency staff were uncertain if the Phase 3 trial surrogate endpoint (reduction in liver fibrosis) would actually translate into benefit for patients. While the agency invited the committee to resubmit with longer-term data from the Phase 3 trial, the newsletter says, Intercept complained about the agency decision.

In a statement, company CEO **Mark Pruzanski** criticized FDA for canceling the advisory committee meetings, said the agency review was incomplete, and accused FDA of repeatedly moving the goalposts for approval in a way that could prevent the development of new therapies.