The US FDA is considering labeling that calls greater attention to the symptoms of amyloid-related imaging abnormalities to ensure proper treatment and avoid misclassification as ischemic stroke.
The US Food and Drug Administration’s review and expected approval of Eli Lilly and Company’s donanemab could lead to another safety labeling update for the class of anti-amyloid therapies in Alzheimer’s disease.
The agency is considering requiring that labeling and other materials call greater attention to the symptoms of amyloid-related imaging abnormalities...
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.
