Canada, UK weighing Lecanemab as early Alzheimer’s treatment
Therapy was granted accelerated approval in the US earlier this year
Eisai and Biogen are seeking approval in Canada and the U.K. for lecanemab to treat early Alzheimer’s disease. It’s available under the name Leqembi in the U.S.
Health Canada has accepted the application for review, while the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated lecanemab for its Innovative Licensing and Access Pathway, which is intended to speed up the process leading to marketing therapies that could fill an unmet need in treating serious diseases.
The applications have largely been met with excitement from members of the Alzheimer’s community.
“This news gives hope to the hundreds of thousands of Canadians at heightened risk of developing Alzheimer’s disease that treatments will be available to help them,” Cathy Barrick, CEO of the Alzheimer Society of Ontario, said in a press release.
While the news was welcomed, the society said healthcare must be improved to provide optimal care. It usually takes more than a year for someone in Ontario to get formally diagnosed and if the therapy is made available, the wait time could extend past seven years — longer than the life expectancy for many seeking a diagnosis.
“Industry has done its part, developing effective treatments. People living with dementia have done their part, participating in clinical research. Regulators are doing their part, reviewing findings to get breakthrough treatments to Canadians who need them. It’s up to our elected officials and decision makers to get ready for what we now know is coming: Canada’s first-ever approved treatment for Alzheimer’s disease,” Barrick said. “Ontarians are watching. We have no time to lose.”
Applications for lecanemab being considered in Japan, China, EU
Alzheimer’s is marked by aggregates (clumps) of a protein called amyloid-beta forming in the brain. These aggregates are believed to be toxic and contribute to the disease.
Lecanemab is an antibody-based therapy designed to help clear these protein aggregates. Its developers are seeking its approval for patients in the early stages of Alzheimer’s for whom amyloid-beta aggregates show up on imaging tests.
“This treatment, or any treatment, won’t be for everyone. But it is the first in what we hope will be an array of numerous treatments for Alzheimer’s disease and, eventually, all forms of dementia,” Barrick said. “It is vital that we get the introduction of this first treatment right.”
The applications are based primarily on data from the Phase 3 CLARITY AD trial (NCT03887455), which tested lecanemab against a placebo in 1,795 people with early Alzheimer’s. After 18 months, the rate of decline in a standardized measure of cognitive function was significantly reduced by 27% with lecanemab, results showed.
The therapy is already being considered for potential approvals in Japan, China, and the European Union. In the U.S., lecanemab was granted accelerated approval this year. This allows it to be marketed based on early clinical data that showed it can clear amyloid-beta clumps as intended.
The U.S. Food and Drug Administration (FDA) is considering converting this to a traditional approval, based mainly on data from CLARITY AD. An advisory committee meeting to discuss the application is set for June 9, with a final decision set for July.