The U.S. Food and Drug Administration (FDA) has now approved LEQEMBI under the traditional pathway making it the first approved treatment for early AD with a significant reduction in disease progression rate and slowing cognitive and functional decline. It marks Eisai’s success in research collaboration with Biogen and BioArctic for joint development and commercialization of AD treatments.
LEQEMBI (lecanemab-irmb) is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody designed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ) for patients with mild cognitive impairment (MCI) or mild dementia stage of AD (collectively referred to as early AD). One of the side effects of LEQEMBI, however, is amyloid-related imaging abnormalities (ARIA), especially among ε4 homozygotes of APOE. It is, therefore, recommended that prior genotyping for APOE is desirable. But this will not prevent any patient from receiving the treatment.
Medicare has already announced that it will cover the treatment for eligible patients. The inclusion criteria are early AD with documented amyloid-beta plaques, the treating doctor must have an appropriate clinical team and follow-up care and participates in a qualifying registry. Currently, the annual worth of treatment with LEQEMBI will cost $26,500. Patients will, however, have to pay 20% of the cost of the drug as a co-payment, making it less affordable for many as a vast majority of Medicare enrollees have an annual income of less than $30,000.
