TOKYO and CAMBRIDGE,
Mass., Dec. 4, 2024 /PRNewswire/ -- Eisai Co.,
Ltd. (Headquarters: Tokyo, CEO:
Haruo Naito, "Eisai") and Biogen
Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced
today that the Federal Commission for the Protection Against
Sanitary Risk (COFEPRIS) in Mexico
has approved humanized anti-soluble aggregated amyloid-beta (Aβ)
monoclonal antibody "LEQEMBI®" (lecanemab) for the
treatment of early Alzheimer's disease (AD)*.
LEQEMBI selectively binds to soluble Aβ aggregates
(protofibrils**), as well as insoluble Aβ aggregates (fibrils)
which are a major component of Aβ plaques, thereby reducing both Aβ
protofibrils and Aβ plaques in the brain. LEQEMBI is the first
approved treatment shown to reduce the rate of disease progression
and to slow cognitive and functional decline through this
mechanism. LEQEMBI is also approved and being marketed in the U.S.,
Japan, China, South
Korea, Hong Kong,
Israel, the United Arab
Emirates, and Great
Britain.
LEQEMBI's approval is based on the large global Phase 3 Clarity
AD study. In the Clarity AD study, LEQEMBI met its primary endpoint
and all key secondary endpoints with statistically significant
results.1,2
Approximately 1.3 million people in Mexico are estimated to suffer from AD,
accounting for 60-70% of all dementia diagnoses.3
AD most commonly affects individuals over the age of
65.3
Eisai serves as the lead of LEQEMBI development and regulatory
submissions globally with both Eisai and Biogen co-commercializing
and co-promoting the product and Eisai having final decision-making
authority. Eisai and Biogen will co-commercialize and co-promote
LEQEMBI in Mexico.
* Collectively referred to mild cognitive impairment due to AD
or mild AD dementia.
** Protofibrils are believed to contribute to the brain injury
that occurs with AD and are considered to be the most toxic form of
Aβ, having a primary role in the cognitive decline associated with
this progressive, debilitating
condition.4 Protofibrils cause injury to neurons in
the brain, which in turn, can negatively impact cognitive function
via multiple mechanisms, not only increasing the development of
insoluble Aβ plaques but also increasing direct damage to brain
cell membranes and the connections that transmit signals between
nerve cells or nerve cells and other cells. It is believed the
reduction of protofibrils may prevent the progression of AD by
reducing damage to neurons in the brain and cognitive
dysfunction.5
Notes to Editors
1. About lecanemab
(LEQEMBI®)
Lecanemab is the result of a strategic research
alliance between Eisai and BioArctic. It is a humanized
immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against
aggregated soluble (protofibril) and insoluble forms of
amyloid-beta (Aβ).
Lecanemab is approved and being marketed in the U.S., Japan, China,
South Korea, Hong Kong, Israel, the United
Arab Emirates and Great
Britain for the treatment of Alzheimer's disease (AD) in
patients with Mild Cognitive Impairment (MCI) or mild dementia
stage of disease (collectively referred to as early AD). The
treatment's approvals in these countries was based on Phase 3 data
from Eisai's global Clarity AD clinical trial, in which it met its
primary endpoint and all key secondary endpoints with statistically
significant results.1,2 The most common adverse
events (>10%) in the lecanemab group were infusion reactions,
ARIA-H (combined cerebral microhemorrhages, cerebral
macrohemorrhages, and superficial siderosis), ARIA-E
(edema/effusion), headache, and fall.
Lecanemab is under regulatory review in 16 countries and regions,
including the European Union. In November
2024, the treatment received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recommending approval.
Since July 2020 the Phase 3 clinical
study (AHEAD 3-45) for individuals with preclinical AD, meaning
they are clinically normal and have intermediate or elevated levels
of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as
a public-private partnership between the Alzheimer's Clinical Trial
Consortium that provides the infrastructure for academic clinical
trials in AD and related dementias in the U.S, funded by the
National Institute on Aging, part of the National Institutes of
Health, Eisai and Biogen. Since January
2022, the Tau NexGen clinical study for Dominantly Inherited
AD (DIAD), that is conducted by Dominantly Inherited Alzheimer
Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in
St. Louis, is ongoing and includes
lecanemab as the backbone anti-amyloid therapy.
2. About the Collaboration
between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the
joint development and commercialization of AD treatments since
2014. Eisai serves as the lead of lecanemab development and
regulatory submissions globally with Eisai and Biogen
co-commercializing and co-promoting the product and Eisai having
final decision-making authority.
3. About the Collaboration
between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a
long-term collaboration regarding the development and
commercialization of AD treatments. Eisai obtained the global
rights to study, develop, manufacture and market lecanemab for the
treatment of AD pursuant to an agreement with BioArctic in
December 2007. The development and
commercialization agreement on the antibody lecanemab back-up was
signed in May 2015.
4. About Eisai Co.,
Ltd.
Eisai's Corporate Concept is "to give first
thought to patients and people in the daily living domain, and to
increase the benefits that health care provides." Under this
Concept (also known as human health care (hhc)
Concept), we aim to effectively achieve social good in the form of
relieving anxiety over health and reducing health disparities. With
a global network of R&D facilities, manufacturing sites and
marketing subsidiaries, we strive to create and deliver innovative
products to target diseases with high unmet medical needs, with a
particular focus in our strategic areas of Neurology and
Oncology.
In addition, we demonstrate our commitment to
the elimination of neglected tropical diseases (NTDs), which is a
target (3.3) of the United Nations Sustainable Development Goals
(SDGs), by working on various activities together with global
partners.
For more information about Eisai, please
visit www.eisai.com (for global headquarters: Eisai. Co.,
Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.)
or www.eisai.eu (for Europe, Middle
East, Africa, Russia, Australia and New
Zealand headquarters: Eisai Europe Ltd.), and connect with
us on X (global and U.S), LinkedIn
(for global, U.S. and EMEA) and Facebook
(global).
5. About Biogen
Founded in 1978, Biogen is a leading
biotechnology company that pioneers innovative science to deliver
new medicines to transform patients' lives and to create value for
shareholders and our communities. We apply deep understanding of
human biology and leverage different modalities to advance
first-in-class treatments or therapies that deliver superior
outcomes. Our approach is to take bold risks, balanced with return
on investment to deliver long-term growth.
The company routinely posts information that may
be important to investors on its website at www.biogen.com.
Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking
statements, about the potential clinical effects of lecanemab; the
potential benefits, safety and efficacy of lecanemab; potential
regulatory discussions, submissions and approvals and the timing
thereof; the treatment of Alzheimer's disease; the anticipated
benefits and potential of Biogen's collaboration arrangements with
Eisai; the potential of Biogen's commercial business and pipeline
programs, including lecanemab; and risks and uncertainties
associated with drug development and commercialization. These
statements may be identified by words such as "aim," "anticipate,"
"believe," "could," "estimate," "expect," "forecast," "intend,"
"may," "plan," "possible," "potential," "will," "would" and other
words and terms of similar meaning. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. Results in early-stage clinical
studies may not be indicative of full results or results from later
stage or larger scale clinical studies and do not ensure regulatory
approval. You should not place undue reliance on these
statements.
These statements involve risks and uncertainties
that could cause actual results to differ materially from those
reflected in such statements, including without limitation
unexpected concerns that may arise from additional data, analysis
or results obtained during clinical studies; the occurrence of
adverse safety events; risks of unexpected costs or delays; the
risk of other unexpected hurdles; regulatory submissions may take
longer or be more difficult to complete than expected; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of Biogen's
drug candidates, including lecanemab; actual timing and content of
submissions to and decisions made by the regulatory authorities
regarding lecanemab; uncertainty of success in the development and
potential commercialization of lecanemab; failure to protect and
enforce Biogen's data, intellectual property and other proprietary
rights and uncertainties relating to intellectual property claims
and challenges; product liability claims; and third party
collaboration risks, results of operations and financial condition.
The foregoing sets forth many, but not all, of the factors that
could cause actual results to differ from Biogen's expectations in
any forward-looking statement. Investors should consider this
cautionary statement as well as the risk factors identified in
Biogen's most recent annual or quarterly report and in other
reports Biogen has filed with the U.S. Securities and Exchange
Commission. These statements speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements.
References
- Eisai presents full results of lecanemab Phase 3 confirmatory
Clarity AD study for early Alzheimer's disease at Clinical Trials
on Alzheimer's Disease (CTAD) conference. Available at:
https://www.eisai.com/news/2022/news202285.html
- van Dyck, H., et al. Lecanemab in Early Alzheimer's Disease.
New England Journal of Medicine. 2023;388:9-21.
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
- Secretaría de Salud. Enfermedad de Alzheimer, demencia más
común que afecta a personas adultas mayores. Oct
2021. https://www.gob.mx/salud/es/articulos/enfermedad-de-alzheimer-demencia-mas-comun-que-afecta-a-personas-adultas-mayores?idiom=e
- Amin L, Harris DA. Aβ receptors specifically recognize
molecular features displayed by fibril ends and neurotoxic
oligomers. Nat
Commun. 2021;12:3451.
doi:10.1038/s41467-021-23507-z
- Ono K, Tsuji M. Protofibrils of Amyloid-β are Important
Targets of a Disease-Modifying Approach for Alzheimer's Disease.
Int J Mol Sci. 2020;21(3):952. doi:
10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/leqembi-lecanemab-approved-for-the-treatment-of-early-alzheimers-disease-in-mexico-302322515.html
SOURCE Eisai Inc.