Health Canada has accepted the application for review, while the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has designated lecanemab for its Innovative Licensing and Access Pathway, which aims to accelerate the process leading to marketing therapies that can fill an unmet need by treatment of serious illnesses.
The applications have largely been met with enthusiasm from members of the Alzheimer’s community.
“This news gives hope to the hundreds of thousands of Canadians at increased risk of developing Alzheimer’s disease that treatments will be available to help them,” Cathy Barrick, executive director of the Alzheimer Society of Ontario, said in a news release.
While the news was welcomed, the community said healthcare needs to improve to provide optimal care. It usually takes more than a year for someone in Ontario to be formally diagnosed, and if the therapy is made available, the wait can stretch to seven years — longer than the life expectancy of many seeking a diagnosis.
“The industry has done its part by developing effective treatments. People living with dementia have done their part by participating in clinical research. Regulators are doing their part and reviewing the results to get breakthrough treatments to Canadians who need them. It is up to our elected officials and policy makers to prepare for what we now know is coming: Canada’s first ever approved treatment for Alzheimer’s disease,” said Barrick. “Ontarians are watching. We have no time to lose.”
Applications for lecanemab are being considered in Japan, China, the EU
Alzheimer’s is characterized by aggregates (clumps) of a protein called amyloid-beta that form in the brain. These aggregates are believed to be toxic and contribute to the disease.
Lecanemab is an antibody-based treatment designed to help remove 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, will not be for everyone. But it is the first in what we hope will be a series of several treatments for Alzheimer’s disease and ultimately all forms of dementia,” Barrick said. It is crucial that we get the introduction of this first treatment right.”
The applications are primarily based on data from the phase 3 CLARITY AD study (NCT03887455), which tested lecanemab against placebo in 1,795 people with early Alzheimer’s. After 18 months, the decline in a standardized measure of cognitive function was significantly reduced by 27% with lecanemab, results showed.
The treatment is already being considered for potential approvals in Japan, China and the EU. In the US, lecanemab received accelerated approval this year. This allows it to be marketed based on early clinical data that showed it can remove amyloid-beta clumps as intended.
The US Food and Drug Administration (FDA) is considering converting this to a traditional approval, based largely on data from the CLARITY AD. An advisory committee meeting to discuss the application is set for June 9, with a final decision due in July.