Dementia Australia has welcomed the approval of the “truly historic” Alzheimer’s drug, lecanemab, by the United States Food and Drug Administration (FDA).
Lecanemab made headlines around the world recently after groundbreaking research showed positive signs in decreasing the rate of cognitive decline among Alzheimer’s patients.
During the Clinical Trials on Alzheimer’s Disease Conference in San Francisco on Wednesday, November 30, 2022 pharmaceutical company, Eisai, presented data from their successful phase 3 clinical trial of lecanemab.
The results, published in the New England Journal of Medicine, demonstrated that the drug was able to slow the rate of decline in people’s memory and thinking as well as function over 18 months, and also helped people manage day-to-day activities.
In a phase 3 trial, participants with early Alzheimer’s disease who received the monoclonal antibody lecanemab had less decline on measures of cognitive function at 18 months than those who received placebo. https://t.co/NjEloWVk1V pic.twitter.com/n33yjV9117
— NEJM (@NEJM) November 30, 2022
The study, conducted by Eisai and Biogen, involved a total of 1795 participants in the early stages of Alzheimer’s disease, with 898 of the participants assigned to receive lecanemab and 897 to receive placebo.
Over 18 months, the rate of cognitive decline among participants slowed by 27 per cent when compared to those who received the placebo.
Following the announcement, the Director of Research at Alzheimer’s Research UK, Dr Susan Kohlhaas said the findings “represent a major step forward for dementia research and could herald a new era for people with Alzheimer’s disease”.
“This is the first time a drug has been shown to both reduce the disease in the brain and slow memory decline in clinical trials,” Kohlhaas said at the time.
Although lecanemab is not yet available in Australia and will require approval for use by the Therapeutic Goods Administration (TGA), Dementia Australia CEO Maree McCabe AM said its approval in the US was exciting news for those impacted by Alzheimer’s disease across the globe.
“This announcement provides further hope for people who are developing symptoms and who are in the early stages of Alzheimer’s disease,” McCabe said.
“With dementia the second leading cause of death of Australians, and the leading cause of death of Australian women, I welcome any steps taken towards improving the lives of people living with dementia, their families and carers.
“I do however acknowledge that lecanemab has only been approved by the FDA for use within the United States and comes with possible side effects that need to be carefully monitored by health professionals.”
Dementia Australia welcomes the announcement by the United States Food and Drug Administration approving lecanemab, a new disease modifying treatment for people living with the early stages of Alzheimer’s disease. More information: https://t.co/HAgXpOku9J pic.twitter.com/ckRB6pDsUB
— Dementia Australia (@DementiaAus) January 12, 2023
Dementia Australia Honorary Medical Advisory Associate Professor Michael Woodward AM said the approval “is an advancement in our progress towards finding a treatment for Alzheimer’s disease”.
“A trial of the drug found a 27 per cent decline in disease progression over 18-months,” Woodward explained.
“What this means is that if you took the drug for two years you would be up to nine months better off and that is a significant benefit.
“It means nine months longer with our loved ones, nine months longer of doing the things we love.
“It is however important to note that lecanemab can cause side effects and that these need to be carefully monitored with regular brain scans.
“I see lecanemab as an important step and a move in the right direction for treating Alzheimer’s disease for which we still do not have a cure.”
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