Health Canada Accepts New Drug Submission for Lecanemab as
Treatment for Early Alzheimer’s Disease
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 Health Canada has accepted a New Drug Submission (NDS)
for lecanemab (brand name in the U.S.: LEQEMBI™), an
investigational anti-amyloid beta (Aβ) protofibril* antibody, for
the treatment of early Alzheimer’s disease (mild cognitive
impairment due to Alzheimer’s disease (AD) and mild AD dementia)
with confirmed amyloid pathology in the brain.
The NDS is based on the results of the Phase III
Clarity AD study and Phase IIb clinical study (Study 201), which
demonstrated the lecanemab treatment showed a reduction of clinical
decline in early AD. Lecanemab selectively binds and eliminates
soluble, toxic Aβ aggregates (protofibrils) that are thought to
contribute to the neurotoxicity in AD. As such, lecanemab may have
the potential to have an effect on disease pathology and to slow
down the progression of the disease. The Clarity AD study of
lecanemab met its primary endpoint and all key secondary endpoints
with highly statistically significant results. In November 2022,
the results of the Clarity AD study were presented at the 2022
Clinical Trials on Alzheimer’s Disease (CTAD) conference, and
simultaneously published in the New England Journal of Medicine, a
peer-reviewed medical journal.
Lecanemab was approved under the accelerated
approval pathway in the U.S. and was launched in the U.S. on
January 18, 2023. The accelerated approval was based on Phase II
data that demonstrated that lecanemab reduced the accumulation of
Aβ plaque in the brain, a defining feature of AD, and its continued
approval may be contingent upon verification of lecanemab’s
clinical benefit in a confirmatory trial. The U.S. Food and Drug
Administration (FDA) determined that the results of Clarity AD can
serve as the confirmatory study to verify the clinical benefit of
lecanemab.
In the U.S., Eisai submitted a supplemental
Biologics License Application (sBLA) to the FDA for approval under
the traditional pathway on January 6, 2023. On March 3, 2023, the
FDA accepted Eisai’s sBLA based on the Clarity AD clinical data,
and the lecanemab application has been granted Priority Review,
with a Prescription Drug User Fee Act (PDUFA) action date of July
6, 2023. The FDA is planning to hold an Advisory Committee to
discuss this application on June 9, 2023. In Japan, Eisai submitted
an application for manufacturing and marketing approval to the
Pharmaceuticals and Medical Devices Agency (PMDA) on January 16,
2023. Priority Review was granted by the Ministry of Health, Labour
and Welfare (MHLW) on January 26, 2023. Eisai utilized the PMDA’s
prior assessment consultation system, with the aim of shortening
the review period for lecanemab. In Europe, Eisai submitted a
marketing authorization application (MAA) to the European Medicines
Agency (EMA) on January 9, 2023, which was accepted on January 26,
2023. In China, Eisai initiated submission of data for a BLA to the
National Medical Products Administration (NMPA) of China in
December 2022, and Priority Review was granted on February 27,
2023.
Eisai serves as the lead of lecanemab
development and regulatory submissions globally with both Eisai and
Biogen co-commercializing and co-promoting the product and Eisai
having final decision-making authority.
* Protofibrils are large Aβ aggregated soluble
species of 75-5000 Kd.1
1 Söderberg, L., Johannesson, M., Nygren,
P. et al. Lecanemab, Aducanumab, and Gantenerumab - Binding
Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy
and Side Effects in Clinical Trials for Alzheimer’s Disease.
Neurotherapeutics (2022).
https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9,
2023
Contacts |
MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL:
+81-(0)3-3817-5120Eisai Inc. (U.S.)Libby HolmanTEL:
+1-201-753-1945Libby_Holman@eisai.comINVESTOR CONTACT:Eisai Co.,
Ltd.Investor Relations DepartmentTEL: +81-(0)3-3817-5122 |
MEDIA CONTACT:Biogen Inc.Jack Cox +
1-210-544-7920public.affairs@biogen.comINVESTOR CONTACT:Biogen
Inc.Chuck Triano+1-781-464-2442 IR@biogen.com |
[Notes to editors]
1. About Lecanemab
Lecanemab (Brand Name in the U.S.: LEQEMBI™) is the result of a
strategic research alliance between Eisai and BioArctic. Lecanemab
is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody
directed against aggregated soluble (protofibril) and insoluble
forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted
accelerated approval by the U.S. Food and Drug Administration (FDA)
on January 6, 2023. LEQEMBI is indicated for the treatment of
Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should
be initiated in patients with mild cognitive impairment or mild
dementia stage of disease, the population in which treatment was
initiated in clinical trials. There are no safety or effectiveness
data on initiating treatment at earlier or later stages of the
disease than were studied. This indication is approved under
accelerated approval based on reduction in Aβ plaques observed in
patients treated with LEQEMBI. Continued approval for this
indication may be contingent upon verification of clinical benefit
in a confirmatory trial.
Please see full
Prescribing Information in the United
States.
Eisai has completed lecanemab subcutaneous
bioavailability study, and subcutaneous dosing is currently being
evaluated in the Clarity AD OLE.
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. 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, has been
ongoing since January 2022.
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 both companies
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, our continued commitment to the
elimination of neglected tropical diseases (NTDs), which is a
target (3.3) of the United Nations Sustainable Development Goals
(SDGs), is demonstrated by our work on various activities together
with global partners.
For more information about Eisai, please visit
www.eisai.com (for global headquarters: Eisai Co., Ltd.), and
connect with us on Twitter, LinkedIn and Facebook.
5. About
Biogen
Founded in 1978, Biogen is a leading global
biotechnology company that has pioneered multiple breakthrough
innovations including a broad portfolio of medicines to treat
multiple sclerosis, the first approved treatment for spinal
muscular atrophy, and two co-developed treatments to address a
defining pathology of Alzheimer’s disease. Biogen is advancing a
pipeline of potential novel therapies across neurology,
neuropsychiatry, specialized immunology and rare diseases and
remains acutely focused on its purpose of serving humanity through
science while advancing a healthier, more sustainable and equitable
world.
The company routinely posts information that may
be important to investors on its website at www.biogen.com.
Follow Biogen on social media – Twitter, LinkedIn, Facebook,
YouTube.
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made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, 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
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unexpected concerns that may arise from additional data, analysis
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