Doctors are urging the FDA to convene an expert panel to review safety concerns around an Alzheimer's drug that won accelerated approval in January, citing reports of 'brain swelling, brain bleeding and death.'
found that while the lecanemab trial represents "an important milestone," there's still a need for "a thorough appraisal of the data" to indicate whether the results are clinically meaningful.
Alzheimer's disease "is a very slowly progressive condition without treatment. And so, you add a treatment that slows it a little bit more," but "it's really not perceptible day-to-day to the patients and the families," said Constantine Lyketsos, an Alzheimer's researcher at Johns Hopkins School of Medicine.Lecanemab targets amyloid plaques, proteins in the brain that are believed to contribute to the development of Alzheimer's.
Lecanemab is the third drug that FDA has used beta amyloid PET scans "to decide whether they're going to grant accelerated approval, and yet we've never had a public discussion of the data to support the use of that endpoint," Karlawish added.
"Very positive results in the trial on multiple outcomes and biomarkers don't historically go to an advisory committee," she added. Apostolova told Axios that she has worked as a consultant for Eisai on lecanemab, and said that if an advisory meeting is called, she would not participate as a result.
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