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.

Drug Review Profile: Leqembi
The primary clinical efficay endpoint's failure to hit its prespecified mark was no hurdle to accelerated approval. • Source: Pink Sheet/Shutterstock

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