Antiviral wins unanimous endorsement on strength of efficacy data in two animal models and absence of major safety concerns in humans. FDA's advisors also see potential utility in other orthopoxviruses, particularly naturally occurring monkeypox outbreaks in Africa.
A US FDA advisory committee unanimously endorsed the approval of Siga Technologies Inc.’s Tpoxx (tecovirimat) as a treatment for smallpox May 1 but also saw opportunities for the antiviral’s study and use in other orthopoxviruses.
The Antimicrobial Drugs Advisory Committee voted 17-0 that the risk-benefit profile of tecovirimat supports its use for treatment of smallpox....
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.
