Ahead of advisory committee vote on accelerated approval, agency takes a dim view of obeticholic acid's benefit-risk balance for the treatment of liver fibrosis due to NASH, citing risks of drug-induced liver injury and morbidity associated with biopsies necessary for appropriate patient selection.
Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) has a “modest” treatment effect on a surrogate endpoint but poses “substantial” risks in the treatment of nonalcoholic steatohepatitis (NASH) that cannot be readily mitigated, the US Food and Drug Administration said.
In a briefing document released ahead of a 19 May meeting of the Gastrointestinal Drugs Advisory Committee, the agency takes...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
