Two-and-a-half years after Aduhelm’s tumultuous advisory committee, FDA finally gets positive vote it was looking for, albeit on a different product. Leqembi meeting serves to endorse CDR-SB as clinical endpoint as well as amyloid plaque as surrogate for reduction in decline.
The US FDA’s advisory committee vote on 9 June for Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb) offered a strong endorsement of the product, but also constituted something of a victory lap for the agency itself.
The FDA’s view that a reduction in amyloid plaque is reasonably likely to predict clinical benefit has been born out...
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.
