Antimicrobial Drugs Advisory Committee will consider whether overall benefit-risk assessment is favorable for treatment of candidemia/invasive candidiasis in adults with limited or no treatment options and, if so, the clinical scenario in which rezafungin fulfills an unmet need.
The US Food and Drug Administration is questioning whether Cidara Therapeutics, Inc.’s antifungal rezafungin provides unique benefits and fills an unmet need such that a smaller clinical development program and safety database can suffice for approval.
Efficacy data for rezafungin would appear to support only a “limited use” indication for treatment of candidemia and invasive candidiasis...
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.
