Ocaliva for PBC - FDA Advisory Panel Voting, 13 September 2024

On 13 September 2024, a meeting of the Gastrointestinal Drugs Advisory Committee took place at which supplemental New Drug Application (sNDA) 207999 S-011, for OCALIVA (obeticholic acid) was discussed. The meeting was open to the public and was streamed live on the official FDA YouTube channel.

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An FDA advisory committee voted against approval for obeticholic acid in primary biliary cholangitis without cirrhosis or compensated cirrhosis with portal hypertension, citing ´concern for real possible harm`.

The Gastrointestinal Drug Advisory Committee voted 13 to 1 with no abstentions that the benefits of obeticholic acid (Ocaliva, Intercept Pharmaceuticals) on clinical outcomes in patients with PBC could not be verified with available data from the postmarketing requirement confirmatory trial, 747-302 and the observational study, 747-405.

The committee also voted 10 to 1 with 3 abstentions that obeticholic acid (OCA) did not have a favorable benefit-risk assessment for use as a second-line treatment in the United Stated Prescribing Information population.

Link to Material: https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-agenda-information-september-13-2024-meeting-gastrointestinal-drugs-advisory-committee#event-information

Link to Video: https://www.youtube.com/live/-WL6uINdGLI