Advisory committee sent a clear message that pre-exposure prophylaxis studies are needed in cisgender women, but what those studies might look like, and whether the agency can exercise its statutory authorities to ensure they are conducted, is less clear.
Despite a close vote recommending against approval of Gilead Sciences Inc.’s Descovy (emtricitabine/tenofovir alafenamide) for HIV pre-exposure prophylaxis in cisgender women, a US Food and Drug Administration advisory committee sent Gilead and the agency a clear message: the sponsor needs to perform prevention efficacy studies in this population.
What is less clear, however, is what those studies might look like, and whether the FDA will try to hold...
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.
