In order to compare the levels of amyloid-beta plaque in a composite of brain regions expected to be severely affected by the pathology of Alzheimer’s disease to a brain region expected to be spared from such pathology, amyloid-beta plaque was quantified using positron emission tomography (PET) imaging.
The prescription includes a warning
Leqembi comes with a warning for amyloid-related imaging abnormalities (ARIA), which are known to occur with antibodies from this class.
ARIA is typically asymptomatic, but in rare cases, it can cause serious and potentially fatal complications. The most common symptom of ARIA is temporary swelling in some areas of the brain that usually resolves on its own and may be accompanied by small bleeding spots on or in the brain. However, some individuals may experience symptoms such as headaches, confusion, dizziness, changes in vision, nausea, and seizures.
Additionally, there is a risk of infusion-related reactions with Leqembi, which can cause flu-like symptoms, nausea, vomiting, and changes in blood pressure. The most frequently reported side effects of Leqembi are infusion-related reactions, headaches, and ARIA.
According to the prescribing information for Leqembi, it is approved for the treatment of Alzheimer’s disease. It is recommended that treatment with Leqembi is started in patients who have been diagnosed with mild cognitive impairment or the early stages of dementia, as these are the populations in which the drug has been tested and found to be effective in clinical trials.
The labeling for the drug also states that there is no evidence to support the safety or effectiveness of using Leqembi in patients who have more advanced or earlier stages of Alzheimer’s disease than were studied.
Eisai, the pharmaceutical company that led the study, announced that Leqembi would have an estimated annual cost of $26,500 per patient, though the final cost could vary for each person. The president and CEO of the Alzheimer’s Association, Joanne Pike, also stated her concern that this high cost could make the drug inaccessible for many Americans, particularly those who do not have coverage under the government-funded Medicare program for the elderly.
A new FDA-approved Alzheimer’s medicine slowed cognitive decline in patients
