FDA and Alzheimer’s Medications
Leqembi is a monoclonal antibody that targets the brain’s amyloid plaques. These plaques contribute to the progression of Alzheimer’s disease. The Food and Drug Administration approved the experimental Alzheimer’s drug Leqembi (lecanemab-irmb) for clinical use in patients with early disease. It is recommended for patients in the early stages of dementia and is delivered using repeat infusions. The new anti-amyloid drug targets and affects plaques to potentially slow decline.
The FDA used its accelerated approval pathway to greenlight the drug. This pathway allows expedited approval of drugs. The process is for serious conditions when the drug is “reasonably likely to predict a clinical benefit to patients.” With few treatments for Alzheimer’s available, the FDA’s decision gives hope to millions.
The FDA’s decision was based on the results of clinical trial data showing a reduction in brain amyloid burden for participants with mild cognitive impairment or mild dementia who took Leqembi.
The federal government published a withering report on the approval process for Aduhelm. CMS confined Medicare coverage of Leqembi’s predecessor, aducanumab (Aduhelm), and other drugs in the anti-amyloid class to patients in clinical trials only.
New England Journal of Medicine published a peer-reviewed autopsy analysis. It found that lecanemab with tissue plasminogen activator (tPA) caused brain bleeding and death. It could be causally related or not.
Reuters reported the autopsy “showed extensive brain hemorrhaging, amyloid deposits in the brain, Alzheimer’s disease neuropathologic changes, and inflammation involving amyloid deposits within the blood-vessel walls.” More research and testing will determine safety and efficacy.