Biogen Completes Submission of Biologics License Application to FDA
for Aducanumab as a Treatment for Alzheimer’s Disease
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today
announced that Biogen has completed the submission of a Biologics
License Application (BLA) to the U.S. Food and Drug Administration
(FDA) for the approval of aducanumab, an investigational treatment
for Alzheimer’s disease. The completed submission followed ongoing
collaboration with the FDA and includes clinical data from the
Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1b PRIME
study. As part of the completed submission, Biogen has requested
Priority 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.
“Alzheimer’s disease remains one of the greatest public health
challenges of our time. It robs memories, independence and
eventually the ability to perform basic tasks from the people we
love,” said Michel Vounatsos, Chief Executive Officer at Biogen.
“The aducanumab BLA is the first filing for FDA approval of a
treatment that addresses the clinical decline associated with this
devastating condition, as well as the pathology of the disease. We
are committed to driving progress for the Alzheimer’s disease
community and look forward to the FDA’s review of our filing.”
“People living with Alzheimer’s, their families, caregivers and
so many others in the community are fighting this disease every
day, and the global social burden of the disease is expected to
grow as the population ages,” said Dr. Haruo Naito, Chief Executive
Officer at Eisai Co., Ltd. “The BLA submission is an important step
in the fight against this disease, for which pathophysiological
progression currently cannot be stopped, delayed or prevented.”
The aducanumab clinical development program included two Phase 3
trials, EMERGE and ENGAGE, in patients with early stage Alzheimer’s
disease (enrolled patients had mild cognitive impairment (MCI) due
to Alzheimer’s disease and mild Alzheimer’s disease dementia with
Mini-Mental State Examination (MMSE) scores of 24-30). In EMERGE,
patients who received aducanumab experienced significant slowing of
decline on measures of cognition and function such as memory,
orientation and language. Patients also experienced slowing of
decline on 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.
EMERGE (n=1,638) met its pre-specified primary endpoint, with
patients treated with high dose aducanumab showing a statistically
significant reduction of clinical decline from baseline in Clinical
Dementia Rating-Sum of Boxes (CDR-SB) scores at 78 weeks (22%
versus placebo, P=0.01). In EMERGE, patients treated with high dose
aducanumab also showed a consistent reduction of clinical decline
as measured by the pre-specified secondary endpoints: the
Mini-Mental State Examination (MMSE; 18% versus placebo, P=0.05),
the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13
Items (ADAS-Cog 13; 27% versus placebo, P=0.01) and the Alzheimer’s
Disease Cooperative Study-Activities of Daily Living Inventory Mild
Cognitive Impairment Version (ADCS-ADL-MCI; 40% versus placebo,
P=0.001). Imaging of amyloid plaque deposition in EMERGE
demonstrated that amyloid plaque burden was reduced with low and
high dose aducanumab compared to placebo at 26 and 78 weeks
(P<0.001). While ENGAGE (n=1,647) did not meet its primary
endpoint, Biogen believes a subset of data from ENGAGE are
supportive of the outcome in EMERGE.
The aducanumab clinical program also included the Phase 1b PRIME
study and its long-term extension (LTE) in patients with early
Alzheimer’s disease (enrolled patients had prodromal Alzheimer’s
disease or mild Alzheimer’s disease dementia with MMSE scores of
20-30). The results of this study indicated that aducanumab reduced
amyloid beta plaque in a dose- and time-dependent fashion, and
analyses of exploratory clinical endpoints showed a reduction of
clinical decline (CDR-SB and MMSE, nominally statistically
significant for the 10 mg/kg dose at 12 months), which continued
out to 48 months in the LTE.
“For many people living with the early stages of Alzheimer’s
disease, maintaining independence for as long as possible is the
ultimate goal,” said Stephen Salloway, M.D., M.S., Director of the
Butler Hospital Memory and Aging Program at Brown University. “If
we can help slow the progression from one stage to the next, this
could preserve independence, which, in turn, could have truly
meaningful benefits for people living with the disease and their
loved ones. Aducanumab represents a potential breakthrough that we
hope will provide a treatment foothold in the fight against
Alzheimer’s disease.”
The completion of the BLA submission followed a planned pre-BLA
meeting with the FDA. The FDA now has up to 60 days to decide
whether to accept the application for review, at which point, if
accepted, Biogen expects the FDA will also inform the Company
whether the BLA has been granted Priority Review designation. The
BLA will then be subject to review by the FDA to make a
determination on the potential approval of aducanumab.
In addition to submitting the BLA to the FDA, Biogen has
continued to engage in dialogue with regulatory authorities in
other markets, including Europe and Japan, working diligently
toward the goal of submitting applications in these markets.
About Aducanumab
Aducanumab (BIIB037) is an investigational human monoclonal
antibody studied for the treatment of Alzheimer’s disease. Based on
clinical data, 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 of Aricept®, a treatment for Alzheimer’s disease and
dementia with Lewy bodies, 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, fitness clubs, automobile
makers, retailers, and care facilities. For more information about
Eisai Co., Ltd., please visit http://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 results of the Phase 3
studies and Phase 1b study 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
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.com INVESTOR
CONTACT:Biogen Inc.Joe Mara+781 464 2442IR@biogen.com |
MEDIA CONTACT:Eisai Co.,
Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120 Eisai
Inc.Public Relations DepartmentTEL: +1-551-262-2686 INVESTOR
CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL:
+81-(0)3-3817-5327 |
The PDFs accompanying this press release are available
athttp://ml.globenewswire.com/Resource/Download/2f279c06-860b-4bdd-bf99-3c85795507f8http://ml.globenewswire.com/Resource/Download/30f0908c-96f6-49a9-a9e3-b40f90948df8
Biogen (TG:IDP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2023 to Jul 2024