Use of exploratory methods to understand as much as possible from the two Alzheimer’s disease drug trials that were terminated early for futility is the same type of ‘innovative thinking’ that will be needed to salvage information from neuroscience trials interrupted by the COVID-19, US FDA Office of Neuroscience director Billy Dunn says.
The types of exploratory analyses that Biogen, Inc. and the US Food and Drug Administration are leaning on to conclude Aduhelm (aducanumab) is an effective Alzheimer’s treatment may offer a preview of the regulatory help and flexibility needed to salvage data from clinical trials disrupted by the COVID-19 pandemic.
However, an advisory committee’s rough reception of the results of these analyses for aducanumab portends the challenges inherent with using...
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.
