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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Eisai says ‘narrow’ indication negated need for REMS on amyloid-related imaging abnormalities and hemorrhages in the brain. Unusual nature of accelerated approval and confirmatory trial timing means safety data from the Phase III is barely mentioned in label.
Eisai/Biogen’s lecanemab showed that reducing amyloid can slow Alzheimer’s disease progression, but prescribers will have to weigh the potential benefit versus safety risks on a patient-by-patient basis.
Less than two years after its $101m series A round, Seismic’s machine-learning powered IMPACT platform for biologics drug discovery yielded two clinical trial-ready assets worthy of a $121m series B.