TOKYO and CAMBRIDGE,
Mass., July 5, 2022 /PRNewswire/ -- Eisai Co.,
Ltd. (Headquarters: Tokyo, CEO:
Haruo Naito, "Eisai") and Biogen
Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that
the U.S. Food and Drug Administration (FDA) has accepted the
Biologics License Application (BLA) under the accelerated approval
pathway for lecanemab (development code: BAN2401), an
investigational anti-amyloid beta (Aβ) protofibril antibody for the
treatment of mild cognitive impairment (MCI) due to Alzheimer's
disease (AD) and mild AD (collectively known as early AD) with
confirmed presence of amyloid pathology in the brain. Eisai's
application, which was completed in early May 2022, has been granted Priority Review, with
a Prescription Drug User Fee Act (PDUFA) action date of
January 6, 2023.
"Alzheimer's disease is a serious disease that causes
significant disability and burden to the people living with
Alzheimer's disease and their families. Treatment options for
Alzheimer's disease are limited and creation of new treatment
options is strongly encouraged. Eisai employees have spent time
with people living with Alzheimer's disease to truly understand
their feelings and challenges and have been working to create new
treatments for many years," said Haruo
Naito, Chief Executive Officer at Eisai. "The acceptance of
lecanemab's BLA with priority review is an important milestone in
serving people living with Alzheimer's disease who have been
waiting for new treatment options to address an underlying
pathology of Alzheimer's disease. We will continue to actively
cooperate with the FDA's review in an effort to bring this new
treatment option to people living with Alzheimer's disease and
their families as soon as possible."
"We believe in a future where people living with Alzheimer's
disease will have different treatment options to address this
complex disease, and today's BLA acceptance with priority review by
FDA is an important step towards this vision," said Michel Vounatsos, Chief Executive Officer at
Biogen. "Together with Eisai, we are committed to continuing our
work to address the tremendous unmet need for these patients and
their families."
The Clarity AD Phase 3 clinical study for lecanemab in early AD
is ongoing and Eisai completed enrollment in March 2021 with 1,795 patients. The readout of
the primary endpoint data of Clarity AD will occur in the Fall of
2022. The FDA has agreed that the results of Clarity AD, when
completed, can serve as the confirmatory study to verify the
clinical benefit of lecanemab. Eisai utilized the FDA's
Accelerated Approval Pathway in an effort to streamline the
submission process for the potential traditional approval of
lecanemab in order to expedite patients' access to
lecanemab. Dependent upon the results of the Clarity AD
clinical trial, Eisai will submit for traditional approval of
lecanemab to the FDA during Eisai's fiscal year 2022, which ends on
March 31, 2023.
In Japan, in March 2022, Eisai initiated the submission of
application data to the Pharmaceuticals and Medical Devices Agency
(PMDA) under the prior assessment consultation system with the
aim of obtaining early approval for lecanemab. Eisai aims to file
for the manufacturing and marketing approval based on the results
of Clarity AD during Eisai's fiscal year 2022. Also, in
Europe, based on the results of
the Clarity AD study, Eisai plans to submit a new drug application
in fiscal year 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.
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)70-8688-9685
|
MEDIA
CONTACT:
Biogen Inc.
Ashleigh
Koss
+
1-908-205-2572
public.affairs@biogen.com
INVESTOR
CONTACT:
Biogen Inc.
Mike Hencke
+
1-781-464-2442
IR@biogen.com
|
[Notes to editors]
1. About Lecanemab
(BAN2401)
Lecanemab is an investigational humanized
monoclonal antibody for Alzheimer's disease (AD) that is the result
of a strategic research alliance between Eisai and BioArctic.
Lecanemab selectively binds to neutralize and eliminate soluble,
toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought
to contribute to the neurodegenerative process 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.
Currently, lecanemab is being developed as the only anti- Aβ
antibody that can be used for the treatment of early AD without the
need for titration. With regard to the results from pre-specified
analysis at 18 months of treatment with lecanemab 10 mg/kg IV
biweekly, Study 201 demonstrated reduction of brain Aβ accumulation
(P<0.0001) and slowing of disease progression measured by
ADCOMS* (P<0.05) in early AD patients. The study did not achieve
its primary outcome measure** at 12 months of treatment. The Study
201 open-label extension was initiated after completion of the Core
period and a Gap period off treatment of 9-59 months (average of 24
months, n=180 from core study enrolled) to evaluate safety and
efficacy, and is underway.
Currently, lecanemab is being studied in a confirmatory Phase 3
clinical study in symptomatic early AD (Clarity-AD), following the
outcome of the Phase 2 clinical study (Study 201). 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
Alzheimer's disease (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 in
combination with E2814 MTBR-tau antibody or placebo. Furthermore,
Eisai has initiated a lecanemab subcutaneous dosing Phase 1
study.
* Developed by Eisai, ADCOMS (AD Composite Score) combines items
from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive
subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental
State Examination) scales to enable a sensitive detection of
changes in clinical functions of early AD symptoms and changes in
memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with
higher score indicating greater impairment.
** An 80% or higher estimated probability of demonstrating 25%
or greater slowing in clinical decline at 12 months treatment
measured by ADCOMS from baseline compared to placebo.
2. About the Collaboration between Eisai
and Biogen for Alzheimer's Disease
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 under Eisai's final
decision-making authority.
3. About the Collaboration between Eisai
and BioArctic for Alzheimer's Disease
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
concluded 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.
The
Eisai's Corporate Philosophy 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 Philosophy (also known as
human health care (hhc) philosophy), 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.
Under the medium-term business plan "EWAY Future & Beyond",
which began in April 2021, Eisai is
expanding its main role in healthcare, that is, we should
contribute not only to people in the medical domain but also to
people in the daily living domain. We aim to evolve into an
hhceco (hhc philosophy + eco-system) company that
empowers people "to realize their fullest life" by creating
solutions based on science and data through building an ecosystem
in collaboration with other industries.
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 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 is
providing the first and only approved treatment to address a
defining pathology of Alzheimer's disease. Biogen is also
commercializing biosimilars and focusing on advancing the
industry's most diversified pipeline in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply
interrelated issues of climate, health, and equity. Healthy
Climate, Healthy Lives™ aims to eliminate fossil fuels across the
company's operations, build collaborations with renowned
institutions to advance the science to improve human health
outcomes, and support underserved communities.
The company routinely posts information that may be important to
investors on our website at www.biogen.com. To learn more, please
visit www.biogen.com and 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 expected data readout for the
Clarity AD study; 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.
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SOURCE Eisai Inc.