European Medicines Agency Accepts Biogen’s Aducanumab Marketing
Authorization Application for Alzheimer's Disease
Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
today announced that the European Medicines Agency (EMA) has
confirmed it has accepted for review, following a standard
timetable, the Marketing Authorization Application (MAA) for
aducanumab, an investigational treatment for Alzheimer’s disease.
Clinical data from patients with Mild Cognitive Impairment due to
Alzheimer’s disease and mild Alzheimer’s disease demonstrate that
treatment with aducanumab resulted in the removal of amyloid beta
and better clinical outcomes. If approved, aducanumab would become
the first therapy to reduce the clinical decline in patients with
Alzheimer’s disease.
“Alzheimer’s disease has become a significant and growing burden
for societies around the world, and we believe aducanumab
represents the first breakthrough that can change the course of
this devastating disease,” said Michel Vounatsos, Chief Executive
Officer at Biogen. “We are committed to working with regulatory
authorities worldwide and we look forward to the European Medicines
Agency’s review of this application.”
“There are no treatments available that impact the progression
of Alzheimer’s disease by addressing the underlying disease
pathology. The potential that aducanumab may hold to effectively
reduce the clinical decline brings new hope to people and families
living with this devastating disease,” said Dr. Haruo Naito, Chief
Executive Officer at Eisai Co., Ltd. “The acceptance of the
Marketing Authorization Application in the European Union is an
important milestone as we work towards making this potential
treatment available around the world.”
Aducanumab is also under review with the U.S. Food and Drug
Administration with Priority Review, with a Prescription Drug User
Fee Act (PDUFA) action date of March 7, 2021.
About Aducanumab
Aducanumab (BIIB037) is an investigational human monoclonal
antibody studied for the treatment of Alzheimer’s disease. Based on
clinical data from patients with Mild Cognitive Impairment due to
Alzheimer’s disease and mild Alzheimer’s disease, aducanumab has
the potential to impact underlying disease pathophysiology, slow
cognitive and functional decline and provide benefits on patients’
ability to perform activities of daily living, including conducting
personal finances, performing household chores, such as cleaning,
shopping and doing laundry, and independently traveling out of the
home. If approved, aducanumab would be the first treatment to
meaningfully change the course of the disease for individuals
living with Alzheimer’s.
Biogen licensed aducanumab from Neurimmune under a collaborative
development and license agreement. Since October 2017 Biogen and
Eisai Co., Ltd. have collaborated on the development and
commercialization of aducanumab globally.
EMERGE and ENGAGE were Phase 3 multicenter, randomized,
double-blind, placebo-controlled, parallel-group studies designed
to evaluate the efficacy and safety of aducanumab. The primary
objective of the studies was to evaluate the efficacy of monthly
doses of aducanumab as compared with placebo in reducing cognitive
and functional impairment as measured by changes in the Clinical
Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives
were to assess the effect of monthly doses of aducanumab as
compared to placebo on clinical decline as measured by the
Mini-Mental State Examination (MMSE), Alzheimer’s Disease
Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and
Alzheimer’s Disease Cooperative Study-Activities of Daily Living
Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).
About Alzheimer’s Disease
Alzheimer’s disease is a progressive neurological condition that
impairs thinking, memory and independence, leading to premature
death. The disease currently cannot be stopped, delayed or
prevented and is a growing global health crisis, affecting those
living with the disease and their families. According to the World
Health Organization (WHO), tens of millions of people worldwide
live with Alzheimer’s disease, and the number will grow in the
years ahead, outpacing the healthcare resources needed to manage it
and costing billions of dollars.
The Alzheimer’s Disease International 2019 Alzheimer’s Yearbook
estimates that approximately 10 million people in the EU suffer
from dementia (excluding Mild Cognitive Impairment). AD is
suspected to represent around 60-70% of dementia cases.
Alzheimer’s disease is characterized by changes in the brain,
including the abnormal accumulation of toxic amyloid beta plaque,
which begins approximately 20 years before patients exhibit
symptoms of the disease. Mild Cognitive Impairment due to
Alzheimer’s disease is one of the earliest stages of the disease
when symptoms start to be more visible and can be detected and
diagnosed. Current research efforts are focused on catching and
treating patients as early as possible for the best chance of
slowing or stopping the progression of Alzheimer’s disease.
About Biogen
At Biogen, our mission is clear: we are pioneers in
neuroscience. Biogen discovers, develops and delivers worldwide
innovative therapies for people living with serious neurological
and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and
Phillip Sharp. Today Biogen has the leading portfolio of medicines
to treat multiple sclerosis, has introduced the first approved
treatment for spinal muscular atrophy, commercializes biosimilars
of advanced biologics and is focused on advancing research programs
in multiple sclerosis and neuroimmunology, Alzheimer’s disease and
dementia, neuromuscular disorders, movement disorders,
ophthalmology, immunology, neurocognitive disorders, acute
neurology and pain.
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.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global pharmaceutical company
headquartered in Japan. Eisai’s corporate philosophy is based on
the human health care (hhc) concept, which is to give first thought
to patients and their families, and to increase the benefits that
health care provides to them. With a global network of R&D
facilities, manufacturing sites and marketing subsidiaries, we
strive to realize our hhc philosophy by delivering innovative
products to target diseases with high unmet medical needs, with a
particular focus in our strategic areas of Neurology and
Oncology.
Leveraging the experience gained from the development and
marketing a treatment for Alzheimer’s disease, Eisai aims to
establish the “Eisai Dementia Platform.” Through this platform,
Eisai plans to deliver novel benefits to those living with dementia
and their families through constructing a “Dementia Ecosystem,” by
collaborating with partners such as medical organizations,
diagnostic development companies, research organizations, and
bio-ventures in addition to private insurance agencies, finance
industries, fitness clubs, automobile makers, retailers, and care
facilities. For more information about Eisai Co., Ltd., please
visit https://www.eisai.com.
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 potential
regulatory discussions, submissions and approvals and the timing
thereof; the potential clinical effects of aducanumab; the
potential benefits, safety and efficacy of aducanumab; 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 aducanumab; 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 trials may not be indicative of
full results or results from later stage or larger scale clinical
trials 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 actual timing and
content of submissions to and decisions made by the regulatory
authorities regarding aducanumab; 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 aducanumab; unexpected concerns that may
arise from additional data, analysis or results obtained during
clinical trials; the occurrence of adverse safety events; risks of
unexpected costs or delays; the risk of other unexpected hurdles;
uncertainty of success in the development and potential
commercialization of aducanumab; risks relating to the potential
launch of aducanumab, including preparedness of healthcare
providers to treat patients, the ability to obtain and maintain
adequate reimbursement for aducanumab and other unexpected
difficulties or hurdles; 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.
Contacts |
MEDIA CONTACT:Biogen Inc.David
Caouette+ 617 679 4945public.affairs@biogen.comINVESTOR
CONTACT:Biogen Inc.Joe Mara+781 464 2442IR@biogen.com |
MEDIA CONTACT:Eisai Co.,
Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai
Inc.Public Relations DepartmentTEL: +1-201-753-1945INVESTOR
CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL:
+81-(0)3-3817-5327 |
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