Eisai and Biogen Announce Canadian Health Ministry Grants Conditional Approval for Leqembi, a Humanized Anti-Soluble Aggregating Amyloid-Beta (Aβ) Monoclonal Antibody, for the Treatment of Adult Patients. Leqembi is indicated for the treatment of adults with early Alzheimer's disease (AD), clinically diagnosed with mild cognitive impairment or mild dementia, who are either non-carriers or heterozygous for apolipoprotein E ε4 (ApoE ε4), and confirmed to have amyloid-beta pathology. Leqembi becomes the first treatment targeting the underlying cause of early Alzheimer's disease to be approved in Canada.
Lecanemab selectively binds to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), the latter being the main component of Aβ plaques, thereby reducing Aβ protofibrils and Aβ plaques in the brain. Lecanemab is the first approved treatment for slowing disease progression and delaying cognitive and functional decline in adult patients with AD. It has been approved for marketing in 51 countries and regions, including Japan, the United States, Europe, China, Taiwan, South Korea, and Saudi Arabia, and marketing applications have been submitted in an additional 9 countries.
Alzheimer's disease is the most common type of dementia, accounting for 60% to 80% of all cases. It is estimated that as of January 1, 2025, there will be more than 771,000 people with dementia in Canada, and this number is expected to increase to approximately 1 million by 2030 and exceed 1.7 million by 2050.
Eisai is leading the global development and registration application of lecanemab, while the product will be jointly commercialized and promoted by Eisai and Biogen. Among them, Eisai has the final decision-making power. In Canada, Eisai will be responsible for the distribution of the product and providing relevant information. Eisai and Biogen are committed to working with medical professionals and other stakeholders to jointly promote the early treatment of Alzheimer's disease.
Note: This article is an excerpt of the original information. For detailed report content, please refer tohttp://www.eisai.com/news/index.html。
Disclaimer
1. This press release aims to convey information related to scientific frontiers and the pharmaceutical field, providing an objective presentation of relevant events, developments, and the current status of drugs. It does not constitute, and under no circumstances should be considered as, a recommendation, inducement, or promotion of any drug or treatment regimen.
2. The information contained in this press release is current as of the release date, and subsequent developments may change due to various factors. All actions and statements in this press release strictly adhere to and should comply with applicable laws and regulations as amended from time to time. It should be noted that there is no indication that all information related to the content described is fully and completely included in this press release; there may be instances of incomplete or omitted information.
3. This press release contains certain forward-looking statements based on the information, assumptions, and expectations currently available to management. These statements involve numerous known and unknown risks and uncertainties. Various factors could cause actual results to differ materially from those discussed in the forward-looking statements, including but not limited to changes in economic conditions, adjustments in laws and regulations, progress in product development, competitive market dynamics, and fluctuations in currency exchange rates. Eisai China has no obligation to update any forward-looking statements due to new information, future events, or developments.
4. Eisai China shall not be liable for any losses, whether property loss, profit loss or other types of loss, arising directly or indirectly from the use of or reliance on any information contained in this press release or any omission of information. If the distribution or use of such information violates applicable laws or regulations, no individual or entity in any jurisdiction or country shall distribute or use such information.