Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced
that Biogen led a late-breaking presentation on the design of the
first real-world observational Phase 4 study in Alzheimer’s disease
called ICARE AD-US, at the Alzheimer’s Association International
Conference (AAIC), being held both virtually and in Denver, Colo.
from July 26 – 30, 2021. ICARE AD-US, a prospective study of
ADUHELM™ (aducanumab-avwa) 100 mg/mL solution for injection, is
designed to collect real-world, long-term effectiveness and safety
data on ADUHELM. The virtual oral session (#57522) was titled,
“ICARE AD-US: design of a prospective, single-arm, multicenter,
noninterventional real-world study of aducanumab in United States.”
ADUHELM is indicated for the treatment of Alzheimer’s disease.
Treatment with ADUHELM 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 amyloid beta plaques observed in patients treated with
ADUHELM. Continued approval for this indication may be contingent
upon verification of clinical benefit in confirmatory trial(s).
ICARE AD-US is a real-world study that will provide information
on the long-term effectiveness and safety of ADUHELM as prescribed
in routine clinical practice in the U.S. based on the label
approved by the U.S. Food and Drug Administration (FDA). The
primary objective of the study is to characterize and evaluate
real-world, long-term changes in cognition, function and
neuropsychiatric status in ADUHELM-treated patients. Secondary
objectives are related to gaining a better understanding of ADUHELM
safety in real-world clinical practice.
The study design includes an important goal to help address the
common underrepresentation of Black/African American and Latinx
patients in Alzheimer’s disease studies, aiming to enroll at least
16 percent of the trial’s expected 6,000 participants from these
communities. Alzheimer’s disease clinical trials commonly have one
to two percent enrollment from these groups, even though
Black/African Americans and Latinx people are respectively two and
one-and-a-half times more likely than older White Americans to have
Alzheimer’s disease.
The study intends to enroll patients with Alzheimer’s disease
over four years from approximately 200 sites in the U.S. Patients
will be monitored for a period of up to five years.
“Biogen is committed to both generating new data about ADUHELM
and supporting steps to bring adequate representation to this trial
and other clinical trials from traditionally underrepresented
groups,” said Ivana Rubino, Ph.D., U.S. and Global Head of Medical,
Alzheimer’s Disease at Biogen. “We believe this can help us better
understand the safety and effectiveness of treatment in patients
with Alzheimer’s disease across ethnicities, something that has
challenged researchers in this field for decades. The ICARE AD-US
study, designed in collaboration with Alzheimer’s disease experts,
underscores both of these commitments.”
The ICARE AD-US study is one of three clinical programs designed
to generate new data about ADUHELM. The others include EMBARK, the
ongoing, Phase 3b re-dosing study for eligible patients previously
enrolled in ADUHELM clinical trials, including the PRIME long-term
extension, EMERGE and ENGAGE, and the confirmatory Phase 4 trial
that is in the process of being designed and will be conducted to
verify the clinical benefit of ADUHELM as part of the
post-marketing requirements associated with the accelerated
approval pathway of ADUHELM in the U.S.
“The ICARE AD-US study will provide important information on the
safety, effectiveness and management of Alzheimer’s disease with
ADUHELM, the first approved treatment for Alzheimer’s disease that
targets the amyloid pathway, in the real-world setting across
diverse populations,” said Harald Hampel, M.D., Ph.D., Vice
President, Chief Medical Officer, Neurology Business Group, Eisai
Inc. “It is important for Eisai and the larger scientific community
to recruit patients of diverse ethnicities for clinical trials to
help address health disparities.”
The presentation on the ICARE AD-US study will be available for
30 days on the AAIC conference website. Biogen will also post the
presentation on the investors section of its website at
investors.biogen.com.
About ADUHELM™ (aducanumab-avwa)
injection 100 mg/mL solution
ADUHELM is indicated for the treatment of Alzheimer’s disease.
Treatment with ADUHELM 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 amyloid beta plaques observed in patients treated with
ADUHELM. Continued approval for this indication may be contingent
upon verification of clinical benefit in confirmatory trial(s).
Aducanumab-avwa is a monoclonal antibody directed against
amyloid beta. The accumulation of amyloid beta plaques in the brain
is a defining pathophysiological feature of Alzheimer’s disease.
The accelerated approval of ADUHELM has been granted based on data
from clinical trials showing the effect of ADUHELM on reducing
amyloid beta plaques, a surrogate biomarker that is reasonably
likely to predict clinical benefit, in this case a reduction in
clinical decline.
ADUHELM can cause serious side effects including: Amyloid
Related Imaging Abnormalities or “ARIA”. ARIA is a common side
effect that does not usually cause any symptoms but can be serious.
Although most people do not have symptoms, some people may have
symptoms such as: headache, confusion, dizziness, vision changes
and nausea. The patient’s healthcare provider will do magnetic
resonance imaging (MRI) scans before and during treatment with
ADUHELM to check for ARIA. ADUHELM can also cause serious allergic
reactions. The most common side effects of ADUHELM include:
swelling in areas of the brain, with or without small spots of
bleeding in the brain or on the surface of the brain (ARIA);
headache; and fall. Patients should call their healthcare provider
for medical advice about side effects.
Please see full Prescribing
Information including Medication
Guide.
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, neuropsychiatry, immunology, acute neurology and
neuropathic 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 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, relating to:
Biogen’s strategy and plans; potential of, and expectations for,
Biogen’s commercial business, including ADUHELM; the potential
clinical effects of ADUHELM; the potential benefits, safety and
efficacy of ADUHELM; the identification and treatment of
Alzheimer’s disease; the design and enrollment of the ICARE AD-US
study; the anticipated benefits and potential of our collaboration
arrangements with Eisai; the clinical development program, clinical
trial(s) and data readouts and presentations for ADUHELM; and risks
and uncertainties associated with drug development and
commercialization. These forward-looking statements may be
accompanied by such words as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,”
“plan,” “potential,” “possible,” “prospect,” “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: risks that we may not fully enroll the
ICARE AD-US study or it will take longer than expected; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of our drug
candidates, including ADUHELM; unexpected concerns that may arise
from additional data or analysis obtained during clinical trials;
actual timing and content of submissions to and decisions made by
the regulatory authorities regarding ADUHELM; the occurrence of
adverse safety events, restrictions on use or product liability
claims; risks of unexpected costs or delays; the risk of other
unexpected hurdles; failure to protect and enforce our data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; third party collaboration risks; the direct and
indirect impacts of the ongoing COVID-19 pandemic on our business,
results of operations and financial condition; and any other risks
and uncertainties that are described 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.Allison Parks+ 781 464
3260public.affairs@biogen.comINVESTOR CONTACT:Biogen Inc.Mike
Hencke+781 464 2442IR@biogen.com |
MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL:
+81-(0)3-3817-5120Eisai Inc.Public Relations DepartmentTEL:
+1-201-753-1945 INVESTOR CONTACT:Eisai Co., Ltd.Investor Relations
DepartmentTEL : +81-(0)3-3817-5121 |
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