Eisai Co., Ltd. and Biogen, Inc. should hear from the US Food and Drug Administration any day now whether the agency will grant accelerated approval for the amyloid protofibril-targeting antibody lecanemab, but one issue looming large over the treatment for early Alzheimer’s disease is how safe it will be for frail, elderly patients – particularly for individuals taking anticoagulants for cardiovascular disease or treated in the emergency room for a stroke. A new case study looking at one lecanemab clinical trial participant who died following anticoagulant use attempts to shed some light on the safety concern.
The New England Journal of Medicine (NEJM) published the case study on 4 January in a letter written by Nicholas Reish and 11 other doctors from Northwestern University Feinberg School of Medicine in Chicago, along with a response letter from two investigators involved in Eisai/Biogen’s pivotal Phase III Clarity AD clinical trial, Marwan Sabbagh of