The failure of Eisai Co., Ltd. and Biogen, Inc.’s Phase II Leqembi (lecanemab-irmb) trial on its primary clinical endpoint did not undermine the view that the drug’s ability to lower amyloid plaque is reasonably likely to predict clinical benefit in Alzheimer’s disease, a US Food and Drug Administration clinical reviewer said.
Leqembi Phase II Missed Clinical Endpoint But Still Provided Support For Amyloid Surrogate
Pink Sheet's Drug Review Profile digs into the FDA memos on Eisai/Biogen’s lecanemab; Phase II clinical efficacy results were reviewed for whether they supported the likelihood of amyloid plaque reduction to predict clinical benefit, rather than whether they directly provided substantial evidence of effectiveness.
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