New Alzheimer’s Drug Sees Success, FDA Approval
With the median age of Americans increasing, certain neurodegenerative diseases may be on the horizon for the aging population. Affecting an estimated 6.7 million Americans aged 65 and older, Alzheimer’s disease is a progressive neurological disorder that results in memory and cognitive decline. It is often characterized by confusion, forgetfulness and/or inability to perform daily functions. Despite the high prevalence (roughly one in ten seniors) and extreme effects on the most vulnerable members of the population, there is no cure for Alzheimer’s.
While 80 genetic areas have been identified as associated with the disease, the highest correlation is noted to the presence of β-amyloid peptide buildup in neural tissue. These protein fragments are created from the breakdown of amyloid precursor protein (APP) and form plaques that collect between neurons, disrupting cell function. These plaques are the target of a new drug, Leqembi (lecanemab-irmb). Leqembi is a monoclonal antibody, a lab-synthesized protein made to target singular antigens; in this case, β-amyloid soluble protofibrils (a fiber-looking cluster). The specific targeting to soluble forms is due to the relatively high toxicity of these specific cells, as well as the identifiable arrangement.
While 80 genetic areas have been identified as associated with the disease, the highest correlation is noted to the presence of β-amyloid peptide buildup in neural tissue. These protein fragments are created from the breakdown of amyloid precursor protein (APP) and form plaques that collect between neurons, disrupting cell function. These plaques are the target of a new drug, Leqembi (lecanemab-irmb). Leqembi is a monoclonal antibody, a lab-synthesized protein made to target singular antigens; in this case, β-amyloid soluble protofibrils (a fiber-looking cluster). The specific targeting to soluble forms is due to the relatively high toxicity of these specific cells, as well as the identifiable arrangement.
Alzheimer’s is linked to the accumulation of proteins, namely beta amyloids, in the brain.
Image Source: Raman Oza
The FDA took Phase Three data obtained from 18 months of double-blind, multicenter testing on 1795 Alzheimer’s patients aged 50 to 90, and granted a full traditional approval on July 6th, 2023. For reference, new drugs make it from synthesis to full approval between 5.29 to 17.54% of the time. The process puts drugs under heavy scrutiny, and the FDA’s decision to grant Fast Track, Priority Review, Breakthrough Therapy and Traditional Approval lends credibility to the research provided.
Diving into the research published in the New England Journal of Medicine, the drug had a very explicit study design and testing methodology to determine its degree of success. Split into two groups of 898 and 897 (placebo and 10 milligrams of lecanemab administered biweekly per kilo of body weight intravenously), all participants shared mild cognitive impairment or mild dementia diagnosed as Alzheimer’s disease. This was backed by amyloid presence noted via positron emission tomography (PET) scanning, where radioactive material is injected and scanned by machines to map out structures and functioning of organs.
Results were measured primarily via Clinical Dementia Rating-Sum of Boxes testing (CDR-SE; the range is from 0 to 18 and a high score indicates more impairment), which assesses memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores increased from the patient baseline average of 3.2 in both groups by 1.21 with lecanemab and 1.66 with placebo; this indicated the rate of mental deterioration was less prominent with the tested drug. Secondary analyses on PET scans, Alzheimer’s Disease Assessment Scale (ADAS-cog14), Alzheimer’s Disease Composite Score (ADCOMS), and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) resulted in a significant slowing of mental decline in patients who received lecanemab over the 18 month period over the placebo group.
With these results, as well as successes in prior phases marking as much as a 27% decrease in cognitive decline, lecanemab will soon be utilized with the full backing of the FDA, at a cost of $26,500 per patient per year.
Diving into the research published in the New England Journal of Medicine, the drug had a very explicit study design and testing methodology to determine its degree of success. Split into two groups of 898 and 897 (placebo and 10 milligrams of lecanemab administered biweekly per kilo of body weight intravenously), all participants shared mild cognitive impairment or mild dementia diagnosed as Alzheimer’s disease. This was backed by amyloid presence noted via positron emission tomography (PET) scanning, where radioactive material is injected and scanned by machines to map out structures and functioning of organs.
Results were measured primarily via Clinical Dementia Rating-Sum of Boxes testing (CDR-SE; the range is from 0 to 18 and a high score indicates more impairment), which assesses memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores increased from the patient baseline average of 3.2 in both groups by 1.21 with lecanemab and 1.66 with placebo; this indicated the rate of mental deterioration was less prominent with the tested drug. Secondary analyses on PET scans, Alzheimer’s Disease Assessment Scale (ADAS-cog14), Alzheimer’s Disease Composite Score (ADCOMS), and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) resulted in a significant slowing of mental decline in patients who received lecanemab over the 18 month period over the placebo group.
With these results, as well as successes in prior phases marking as much as a 27% decrease in cognitive decline, lecanemab will soon be utilized with the full backing of the FDA, at a cost of $26,500 per patient per year.
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