
NEJM Interview: Dr. Joseph Ross on shifts in the FDA’s use of accelerated approval and associated challenges for clinicians and patients.
NEJM Interviews
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The FDA Approval of a Monoclonal Antibody for Treating Alzheimer's Disease
Laconimab is a monoclonal antibody for treating Alzheimer's disease that targets beta amyloid. The FDA approved Laconimab through the accelerated approval program on the basis of a surrogate marker changes inbeta amyloid on brain imaging. There are some concerning safety signals as these therapies seem to be associated with an increased risk of brain hemorrhage and micro edema, which resolves when the therapy is discontinued.
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