Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM®
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today
announced additional details about the Phase 4 post-marketing
confirmatory study, ENVISION, of ADUHELM® (aducanumab-avwa)
100 mg/mL injection for intravenous use in early Alzheimer’s
disease, including details of the study’s goal for diverse
enrollment and primary endpoint.
Biogen aims to enroll 18 percent of U.S. participants in
ENVISION from Black/African American and Latinx populations. This
goal is reflective of Biogen’s ongoing commitment to increase
diversity in clinical trials.
“Historically, patients from diverse backgrounds have been
poorly represented in Alzheimer’s disease clinical trials, and we
are committed to changing this,” said Priya Singhal M.D., M.P.H.,
Head of Global Safety & Regulatory Sciences and interim Head of
Research & Development at Biogen. “This goal matches the
diversity among Americans diagnosed with early Alzheimer’s disease,
while at the same time, the trial will generate substantial data to
verify the effectiveness of ADUHELM.”
Biogen will implement multiple strategies to help overcome
barriers to diverse patient enrollment in Alzheimer’s disease
trials, such as, lack of access to medical centers, familiarity
with benefit/risk profile of treatment, and financial or logistical
burdens.
“It’s important to see this ambitious focus on diversity being
prioritized in enrollment and integrated as a key part of the
ENVISION clinical trial, so that we can have data from patients who
more closely represent what we see in the clinic,” said Dylan Wint,
M.D., Cleveland Clinic Lou Ruvo Center for Brain Health,
Nevada.
The companies also announced today that the primary endpoint for
the global, placebo-controlled ENVISION trial will be measured by
the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18
months after treatment initiation with ADUHELM. The CDR-SB endpoint
is a validated measure of both cognition and function that is
widely used in clinical trials of patients with early symptomatic
Alzheimer’s disease, is consistent with ADUHELM’s Phase 3 EMERGE
and ENGAGE studies, and capable of generating robust outcomes. The
update also includes an increase in the previously announced
enrollment, from 1,300 to 1,500 people with early Alzheimer’s
disease (Mild Cognitive Impairment due to Alzheimer’s disease and
mild Alzheimer’s disease), with confirmation of amyloid beta
pathology, to further strengthen the data provided by the
study.
Although ENVISION and other ADUHELM clinical trials are already
planned or underway, the Centers for Medicare and Medicaid Services
(CMS) recently released a draft National Coverage Determination
(NCD), which would restrict Medicare coverage of ADUHELM and other
amyloid-targeting therapies to patients enrolled in an additional
clinical trial. Biogen is committed to engaging with CMS to
avoid unnecessary duplication of clinical trials and work towards
finding a path to offer immediate access to patients to the first
FDA approved treatment for Alzheimer’s disease since 2003.
In addition to the primary endpoint, CDR-SB, secondary endpoints
include Alzheimer's Disease Assessment Scale-Cognitive Subscale
(ADAS-Cog 13), Alzheimer's Disease Cooperative Study - Activities
of Daily Living Inventory - Mild Cognitive Impairment Version
(ADCS-ADL-MCI), Integrated Alzheimer's Disease Rating Scale
(iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric
Inventory (NPI-10).
The initiation of patient screening for ENVISION is planned for
May 2022. Based on enrollment rates from the previous Phase 3
trials with ADUHELM, the primary completion date is expected to be
approximately four years after the study begins. The companies are
grateful to the healthcare professionals, medical centers, patients
and families who will participate in this trial.
Previously, in July 2021, the companies set another substantial
diversity goal in the observational Phase 4 ICARE AD trial, which
aims to enroll a total of approximately 6,000 patients.
About ADUHELM®
(aducanumab-avwa) 100 mg/mL injection for intravenous
useADUHELM 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).
ADUHELM 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.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating
on the global co-development and co-promotion of aducanumab.
Please click here for full Prescribing Information,
including Medication Guide, for ADUHELM.
About BiogenAs 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 its website at www.biogen.com. To learn more,
please visit www.biogen.com and follow Biogen on social
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– 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, about the potential clinical effects
of ADUHELM; the potential benefits, safety and efficacy of ADUHELM;
results from ENVISION; the treatment of Alzheimer’s disease; the
anticipated benefits and potential of Biogen’s collaboration
arrangements with Eisai; clinical development programs, clinical
trials and data readouts and presentations; and risks and
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“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 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; failure to protect and enforce Biogen’s data, intellectual
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intellectual property claims and challenges; risks associated with
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claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
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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
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information, future developments or otherwise.
MEDIA
CONTACT(S):BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.comEisai Inc. (U.S.
Media) Public Relations Department TEL : 1 201
753 1945 Eisai Co., Ltd. (Media Outside the
U.S.) Public Relations Department TEL : +81 (0)3
3817 5120 |
INVESTOR
CONTACT(S):BiogenMike Hencke+1 781 464
2442IR@biogen.com Eisai Co.,
Ltd. Investor Relations Department TEL:
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