Even a more limited label for the dengue vaccine may not be enough to overcome the lack of a readily available and reliable point-of-care diagnostic for screening potential vaccine recipients for previous dengue infection.
Sanofi’s hopes for US FDA approval of its dengue vaccine Dengvaxia may hinge upon a pediatric indication following a strongly negative advisory committee review, particularly regarding licensure for a broader age group.
However, even a more limited label may not be enough to overcome what advisory committee members saw as a key...
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.
