Is Lecanemab Plus t-PA A Deadly Combination? One Case Study May Shed Light
Anticoagulant Use In Spotlight As Approval Nears
Executive Summary
A letter in the New England Journal of Medicine suggests the death of one extension trial participant treated with t-PA may have been caused by lecanemab, but a response notes fatal intracerebral hemorrhages have been seen after t-PA in certain patients in the absence of anti-amyloid drugs.
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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.
No Fast Track For Lecanemab In EU Disappoints Eisai
Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the US FDA’s frequent use of accelerated pathways.
No Fast Track For Lecanemab In EU Disappoints Eisai
Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the FDA’s frequent use of accelerated pathways.