TOKYO and CAMBRIDGE,
Mass., January 29, 2023 /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 an application
for manufacturing and marketing approval for lecanemab (generic
name, U.S. brand name: LEQEMBI™), an anti-amyloid-β (Aβ)
protofibril* antibody, in Japan has been designated for Priority Review
by the Japanese Ministry of Health, Labour and Welfare (MHLW).
Priority Review in Japan is
granted to new medicines recognized as having high medical utility
for serious diseases, and once designated for Priority Review, the
target total review period is shortened.
In Japan, Eisai submitted the
manufacturing and marketing approval for lecanemab to the
Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. This application is based
on the results of the Phase III Clarity AD study and the Phase IIb
clinical study (Study 201), which demonstrated that 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.
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. In
Europe, Eisai submitted a
marketing authorization application (MAA) to the European Medicines
Agency (EMA) on January 9, 2023 and
accepted on January 26, 2023. In
China, Eisai initiated submission
of data for a BLA to the National Medical Products Administration
(NMPA) 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
Department
TEL:
+81-(0)3-3817-5120
Eisai Inc.
(U.S.)
Libby
Holman
+
1-201-753-1945
Libby_Holman@eisai.com
INVESTOR
CONTACT:
Eisai Co.,
Ltd.
Investor Relations
Department
TEL:
+81-(0)03-3817-5122
|
MEDIA
CONTACT:
Biogen Inc.
Natacha
Gassenbach
+
1-857-777-6573
public.affairs@biogen.com
INVESTOR
CONTACT:
Biogen Inc.
Mike Hencke
+
1-781-464-2442
IR@biogen.com
|
[Notes to editors]
1. About Priority
Review in Japan
Priority
review is granted to medicines that meet all of the following
requirements. In addition, medicines designated as orphan drugs and
pioneering medicines will be given priority for review.
i. the qualifying disease is deemed to be serious; and
ii. the efficacy or safety of the product is recognized to be
clearly superior to that of existing medicines, medical devices, or
regenerative medical products or treatment methods from a medical
point of view.
2. 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). 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 submitted an application for manufacturing and marketing
approval to the Pharmaceuticals and Medical Devices Agency (PMDA)
on January 16, 2023 in Japan. Eisai utilized the prior assessment
consultation system of PMDA, with the aim of shortening the review
period for 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. In Europe, Eisai
submitted a marketing authorization application (MAA) to the
European Medicines Agency (EMA) on January
9, 2023 and 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.
Eisai has completed a 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, 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.
3. 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.
4. 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.
5. 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.
6. About Biogen
As 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.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us 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
1.
|
"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.
|
|
|
2.
|
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.
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/lecanemab-receives-priority-review-status-in-japan-301733026.html
SOURCE Eisai Inc.