Statement on FDA approval of lecanemab

On January 6, 2023, the US Food and Drug Administration announced it has granted expedited approval for the Alzheimer’s disease drug lecanemab while the medication continues to be studied in larger clinical trials. You can read more about the approval here.

Drugmakers Biogen and Eisai will apply to European agencies to begin approval processes by the end of March 2023. There is currently no information about the plan to submit the drug for Health Canada approval, which means it will likely be several years before anything is available to the public in Canada.

While lecanemab is not a cure, it “moves the needle” by opening a door for future treatments. The Alzheimer Society of Manitoba is encouraged by research being done on treatments related to dementia. There are currently more than 200 dementia drugs in development internationally. We hear firsthand from members of our community that this wider research trend offers hope to thousands, if not millions, of people.

There have been significant side effects associated with lecanemab. The most commonly noted side effects were reactions to its intravenous administration, headache and ARIA (Amyloid Related Imaging Abnormalities). ARIA side effects include brain swellings and microhemorrhages (i.e., brain bleeds) that are visible on brain scans but they can also be experienced as headaches, confusion, vision changes, dizziness, nausea and seizure.

The Alzheimer Society of Manitoba continues to trust and support Health Canada’s rigorous safety and effectiveness assessments of all drugs related to the treatment of dementia.

Lecanemab will not be suitable for everyone. To be effective, lecanemab requires early detection and diagnosis – which further underscores the importance of continuing to address stigma and ensure more Manitobans have timely access to health-care professionals and a diagnosis.

We will continue to advocate for more research towards both care and cure for people affected by dementia. The Alzheimer Society of Canada, with financial support from Federation partners like the Alzheimer Society of Manitoba has invested more than $67 million in grants and awards to fund innovative research on dementia-related issues.

We are here to provide support to all Manitobans facing dementia today – and are working with others to build communities that are welcoming, supportive and inclusive of people who are affected by dementia.

If you need support, you can call us at 204-943-6622 or 1-800-378-6699.