Aducanumab was the first drug in this category approved by the FDA in June 2021; it is not available for use within Australia.
Lecanemab is a disease modifying treatment for people living with the early stages of Alzheimer's disease or mild cognitive impairment. The drug includes antibodies which are designed to attach to and remove amyloid plaques.
Breakthrough results in a Phase 3 trial for Eli Lilly's Alzheimer's drug treatment Donanemab have shown to significantly slow cognitive and functional decline in persons with mild Alzheimer's disease (AD), the most common cause of dementia in Australia.
A number of drugs are currently available in Australia for use by people with dementia. These drugs fall into two categories, cholinergic treatments and Memantine.
The advisory committee voted against the approval of Aducanumab as a treatment for people with early Alzheimer's disease. The committee felt there was insufficient evidence to show it is effective.
Symptoms include headache, confusion, delirium, altered mental status, disorientation, dizziness, vision abnormality, and nausea—the most common being headache (13%). During the administration of aducanumab infusion, hypersensitivity reactions (angioedema, urticaria) may occur.
Early trial results appear to suggest that new drug donanemab slows the progression of Alzheimer's symptoms by 36%. Alzheimer's Society has released a statement on promising early results from a trial of a new Alzheimer's disease drug called donanemab.
Cholinisterase Inhibitors are the most commonly prescribed medications for dementia. There are 3 cholinisterase inhibitors, which include, Donepezil, Galantamine and Rivastigmine.
Promising treatments
In January, the agency granted accelerated approval to lecanemab, made by Biogen in Cambridge, Massachusetts, and Eisai in Tokyo. A study1 published in November showed that lecanemab slowed cognitive decline in 1,800 patients by 27% over 18 months.
While experts say it's a huge step, it's still no cure. It makes sense why. The disease generates in the brain, the most complicated organ in the body. But a tide may be turning, and doctors hope a cure for Alzheimer's may be here soon.
In June 2021, the U.S. Food and Drug Association (FDA) approved the monoclonal antibody aducanumab (Aduhelm) for the treatment of Alzheimer's disease in some people. The medicine was studied in people living with early Alzheimer's disease, including people with mild cognitive impairment due to Alzheimer's disease.
Lecanemab was approved by the US Food and Drug Administration (FDA) as a treatment for early Alzheimer's disease in January 2023. This means that it can now be given to patients with early Alzheimer's disease in the USA.
Lecanemab is a treatment for people with early-stage Alzheimer's disease who have amyloid in their brain. This means people with other types of dementia, or in the later stages of Alzheimer's disease, are unlikely to benefit from this drug.
Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer's disease. Leqembi is the second of a new category of medications approved for Alzheimer's disease that target the fundamental pathophysiology of the disease.
Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease.
Eli Lilly's donanemab was found to work better than Aduhelm (aducanumab) in a biomarker study of people with early Alzheimer's in removing disease-associated toxic protein clumps in the brain.
Donepezil and rivastigmine
Donepezil tablets are by far the most common medication used to treat dementia. Rivastigmine tends only to be used when donepezil causes side effects, or if the person can't take it for medical reasons.
Acetylcholinesterase inhibitors
Donepezil (also known as Aricept), rivastigmine (Exelon) and galantamine (Reminyl) are used to treat the symptoms of mild to moderate Alzheimer's disease. Donepezil is also used to treat more severe Alzheimer's disease.
Leqembi's annual price tag of $26,500 is below the price set for Aduhelm — which was approved by the FDA in 2021 despite strong objections from its panel of outside advisers. That drug initially cost $56,000 per year before Biogen slashed the price in half, to $28,000 annually.
A clinical trial of donanemab has showed the drug significantly slows cognitive and functional decline in people with early symptomatic disease. It is estimated that almost 400,000 people in Australia had dementia in 2022.
Aducanumab is for people with mild Alzheimer's disease and will require a prescription. As with any medical treatment, appropriateness depends on a variety of factors.
The drug did lower amyloid plaques, but it didn't improve clinical outcomes in Alzheimer's patients. Development of the drug was abandoned in 2012. After the drug was approved, three members of the panel (Joel Perlmutter, David Knopman, and Aaron Kesselheim) resigned in protest.
The statisticians estimate that aducanumab has a 9% likelihood of working based on these two trials, but this is likely much less than that given that numerous interventions that effectively reduce amyloid have failed in RCTs.