There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.
Intercept Pharmaceuticals Inc.'s obeticholic acid (OCA) application for approval in non-alcoholic steatohepatitis (NASH) faces two big review hurdles before the US Food and Drug Administration decides whether the drug can cross the approval finish line.
The first is whether it will be granted priority review. The candidate has a breakthrough designation, which bodes rather well,...
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.
