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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Required studies will assess the risks of ARIA and intracerebral hemorrhage, as well as safety in ApoE ε4 homozygotes. For the required registry-based study, the FDA suggests use of the ALZ-NET platform with no mention of CMS’ newly established registry, which may lack the level of detailed information needed to satisfy the drug regulator’s request.
US FDA will ask its advisory committee to weigh anti-amyloid drug’s benefit-risk in populations at higher risk for adverse events, but agency says lecanemab’s risks ‘do not appear to preclude traditional approval’ and the CLARITY AD trial demonstrated clinical efficacy and a reduction in brain amyloid.
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.