EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER'S DISEASE IN EUROPE
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Tuesday, January 10, 2023
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Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Key Points:
- Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
- There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
- Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
- In Study 1, 15% of LEQEMBI-treated patients, compared to 6% of placebo-treated patients, stopped study treatment because of an adverse reaction.