Is Lecanemab Plus t-PA A Deadly Combination? One Case Study May Shed Light
Anticoagulant Use In Spotlight As Approval Nears
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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CMS will cover Leqembi now that the US FDA has converted Leqembi’s accelerated approval to traditional approval, giving most patients eligible for treatment access to the drug. Updated labeling puts greater emphasis on safety concerns.
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.