Although not tested in smallpox animal models, tecovirimat demonstrated efficacy in surrogate orthopoxvirus disease models in non-human primates and rabbits, FDA says; SIGA seeks approval under the 'Animal Rule' for a broad population of adult and pediatric patients, but agency notes drug's safety has not been clinically tested in children and other vulnerable populations.
Siga Technologies Inc.’s Tpoxx (tecovirimat) appears primed for smooth passage through the US FDA’s Antimicrobial Drugs Advisory Committee given the agency’s conclusion that the smallpox disease treatment has satisfied all the tenets of the “Animal Rule.”
At a May 1 meeting, the advisory committee will be asked to vote on whether, based on the available data,...
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.
