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# Complete Response Letter on Ocaliva sNDA
- URL: https://www.fdaweb.com/complete-response-letter-on-ocaliva-snda/
- Published: 2024-11-12T12:00:00.000Z
- Updated: 2026-09-14T14:46:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158169

FDA has issued Intercept Pharmaceuticals a complete response letter on its supplemental NDA for Ocaliva (obeticholic acid) seeking to convert its accelerated approval to full approval for treating patients with primary biliary cholangitis (PBC). The company says that the letter was consistent with a September Gastrointestinal Drugs Advisory Committee meeting that voted to not recommend full approval for the drug. Panel members agreed with the agency’s finding that Intercept’s confirmatory trial did not show the drug was effective in PBC patients with or without advanced scarring ([see story](https://www.fdaweb.com/ocaliva-confirmatory-trial-fails-fda/)). The reviewers also voiced safety concerns because 11 patients who received the drug during the trial died or needed a liver transplant, compared to two patients who received a placebo.

The letter also said FDA was continuing to consider safety data from Study 747-302, along with other safety information, according to the company, adding that for the time being Ocaliva continues to be available for the treatment of appropriate patients living with PBC under the accelerated approval.