Approval could bring GlaxoSmithKline a tropical disease priority review voucher.
The US FDA is bringing GlaxoSmithKline PLC’s single-dose malaria drug Krintafel (tafenoquine) to a July 12 advisory committee meeting despite apparently having no major concerns about the adequacy of the efficacy and safety data to support approval.
In separate voting questions, the agency asks its Antimicrobial Drugs Advisory Committee whether GSK has provided substantial evidence of effectiveness...
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.
