An anticipated US Food and Drug Administration advisory committee review of Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi (lecanemab-irmb) for regular approval will offer the opportunity for a public vetting on a host of issues.
Transparency In Alzheimer’s: AdComm Expected On Regular Approval For Eisai/Biogen’s Leqembi
While a US FDA advisory committee would focus on efficacy and safety data from Leqembi’s Phase III CLARITY-AD trial, it likely also would provide a public forum for relitigating Audhelm’s accelerated approval and the evidence needed to formally validate amyloid plaque reduction as a surrogate.
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