Advisory committee members warned of dosing errors and other potential problems with the titration/taper regimen used in the clinical trials, arguing a simpler dosing schedule also could increase patient access.
SAGE Therapeutics Inc. may be forced to simplify the dosing regimen for its proposed postpartum depression treatment brexanolone in order to get approval in the US after advisory committee members warned that administration may prove difficult for trained hospital staff.
Such a change might be requested as part of a postmarketing commitment, and while sponsors tend to find such obligations...
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.
