FDA Accepts Biogen’s Aducanumab Biologics License Application for
Alzheimer's Disease with Priority Review
Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted the Biologics License Application (BLA) for aducanumab, an
investigational treatment for Alzheimer’s disease. The application
has been granted Priority Review, with a Prescription Drug User Fee
Act (PDUFA) action date on March 7, 2021, and the FDA has stated
that, if possible, it plans to act early on this application under
an expedited review. If approved, aducanumab would become the first
therapy to reduce the clinical decline of Alzheimer’s disease and
would also be the first therapy to demonstrate that removing
amyloid beta resulted in better clinical outcomes.
“The FDA’s acceptance of the aducanumab BLA with Priority Review
is an important step in the path to potentially having a treatment
that meaningfully changes the course of Alzheimer’s disease,” said
Michel Vounatsos, Chief Executive Officer at Biogen. “We look
forward to working with the FDA throughout the review process and
thank the thousands of clinicians, patients and caregivers who
participated in our clinical trials and have accompanied us on this
journey. We believe that aducanumab marks the beginning of a new
era of potential treatments for Alzheimer’s disease that will
inspire even more discovery and innovation to bring hope to those
affected by this devastating disease.”
“Reducing clinical decline and maintaining the ability to live
an independent life for as long as possible are things that people
living with Alzheimer’s disease and their families value in a
potential treatment,” said Dr. Haruo Naito, Chief Executive Officer
at Eisai Co., Ltd. “If aducanumab is approved, we expect that it
will make a difference in the lives of people living with
Alzheimer’s disease. We believe that this historic milestone is one
step towards creating a paradigm shift in treatment for Alzheimer’s
disease, a public health issue for aging societies.”
Biogen did not use its Priority Review voucher for the
aducanumab BLA. The FDA also stated that it is currently planning
to hold an Advisory Committee meeting for this application on a
yet-to-be-determined date.
“Today, I am heartened by what this progress may mean for people
living with Alzheimer’s disease and their families,” said Dr.
Christopher van Dyck, M.D., Director of the Yale Alzheimer’s
Disease Research Center. “If aducanumab is determined to be
effective in reducing the decline in cognition and activities of
daily living resulting from progression of this disease by
addressing the underlying disease pathology, it will deliver
meaningful benefits to those who most need them.”
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 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.
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
identification and 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
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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 |
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MEDIA CONTACT: Biogen Inc. David
Caouette + 617 679 4945 public.affairs@biogen.com INVESTOR CONTACT:
Biogen Inc. Joe Mara +781 464 2442 IR@biogen.com |
MEDIA CONTACT: Eisai Co., Ltd.
Public Relations Department TEL: +81-(0)3-3817-5120 Eisai Inc.
Public Relations Department TEL: +1-201-753-1945 INVESTOR
CONTACT: Eisai Co., Ltd. Investor Relations Department TEL:
+81-(0)3-3817-5327 |
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