Marketing Authorization Application for Lecanemab as Treatment for
Early Alzheimer’s Disease Accepted by European Medicines Agency
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 European Medicines Agency (EMA) has accepted a
marketing authorization application (MAA) 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, for review
following a standard timeline.
In the U.S., lecanemab was granted accelerated
approval as a treatment for AD by the U.S. Food and Drug
Administration (FDA) on January 6, 2023. On the same day, Eisai
submitted a Supplemental Biologics License Application (sBLA) to
the FDA for approval under the traditional pathway based on the
results from the Phase III Clarity AD confirmatory study. In Japan,
Eisai submitted a marketing authorization application to the
Pharmaceuticals and Medical Devices Agency (PMDA) on January 16,
2023. In China, Eisai has initiated submission of data for a BLA to
the National Medical Products Administration (NMPA) of China in
December 2022.
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 75-500 Kd.1,2
Contacts |
MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL:
+81-(0)3-3817-5120Eisai Europe, Ltd.(Europe, Australia, New Zealand
and Russia)EMEA Communications DepartmentEMEA-comms@eisai.netTEL:
+44-(0)7739-600-678INVESTOR CONTACT:Eisai Co., Ltd.Investor
Relations DepartmentTEL: +81-(0)3-3817-5122 |
MEDIA CONTACT:Biogen Inc.Natacha Gassenbach +
1-857-777-6573public.affairs@biogen.comINVESTOR CONTACT:Biogen
Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com |
[Notes to
editors]1. About
LecanemabLecanemab (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). Lecanemab
selectively binds and eliminates Aβ 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. 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. The Clarity AD study of
lecanemab met its primary endpoint and all key secondary endpoints
with highly statistically significant results.
Please see full
Prescribing Information in the United
States.
Eisai has completed a lecanemab subcutaneous
bioavailability study, and subcutaneous dosing is currently being
evaluated in the Clarity AD (Study 301) 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, has been 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 the
Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led
by Washington University School of Medicine in St. Louis, has been
ongoing.
2. About the
Collaboration between Eisai and Biogen for ADEisai 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 ADSince
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), with working 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 @Eisai_SDGs.
5. About
BiogenAs pioneers in neuroscience, Biogen discovers,
develops, and delivers worldwide innovative therapies for people
living with serious neurological diseases as well as related
therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first approved treatment to address a
defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
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.
Biogen Safe Harbor This news
release contains forward-looking statements, including statements
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
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 or the scientific data
presented.
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, including the Clarity
AD clinical trial and AHEAD 3-45 study; 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; third party collaboration
risks; and the direct and indirect impacts of the ongoing COVID-19
pandemic on Biogen’s business, 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 are based on Biogen’s current
beliefs and expectations and speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
References
- “Lecanemab Sweeps up Toxic AΒ Protofibrils, Catches Eyes of
Trialists.” ALZFORUM, ALZFORUM, 21 Nov. 2021,
https://www.alzforum.org/news/conference-coverage/lecanemab-sweeps-toxic-av-protofibrils-catches-eyes-trialists.
- Sehlin D, Englund H, Simu B,
Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE.
Large aggregates are the major soluble Aβ species in AD brain
fractionated with density gradient ultracentrifugation. PLoS One.
2012;7(2): e32014. doi: 10.1371/journal.pone.0032014. Epub 2012 Feb
15. PMID: 22355408; PMCID: PMC3280222.
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