Gilead and the FDA failed women by letting PrEP application get this far without clinical efficacy data in non-transgendered females, panel members say in close vote against a broad indication; panelists urge the agency to mandate such studies regardless of the breadth of the HIV pre-exposure prophylaxis indication ultimately granted to the Truvada successor.
A divided US Food and Drug Administration advisory committee on 7 August narrowly recommended against including cisgender women in an HIV pre-exposure prophylaxis indication for Gilead Sciences Inc.’s Descovy (emtricitabine/tenofovir alafenamide) due to the lack of clinical efficacy data.
Despite the 10-8 vote against a broad PrEP indication, the committee members were strongly united on one point: the FDA...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
