Biogen and Eisai Announce ADUHELM™ (aducanumab-avwa) Data
Presentations at Alzheimer’s Association International Conference
2021
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today
announced that Biogen, as part of its Alzheimer’s disease (AD)
research portfolio, will contribute four virtual posters that
showcase data from its clinical trials with ADUHELM™
(aducanumab-avwa) injection 100 mg/mL solution at the Alzheimer’s
Association International Conference (AAIC), being held in Denver,
Colo. and virtually from July 26-30, 2021,
ADUHELM was recently granted accelerated approval by the U.S.
Food and Drug Administration (FDA) as a treatment for 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).
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.
“Our presentations to the dementia research community at AAIC of
this robust set of clinical trial data will allow us to engage
directly with scientists and neurologists on in-depth analyses of
our findings,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of
Research and Development at Biogen. “We are looking forward to
sharing our analyses on biomarkers, ARIA and safety management, the
pre-specified clinical endpoints in the Phase 3 ADUHELM trials and
more.”
“The clinical trial results Biogen shared about our joint asset,
ADUHELM, at AAIC are important as we believe the data will help
inform the scientific community as we continue to explore the
strong scientific rationale behind the amyloid beta pathway as one
of the earliest changes that occur in Alzheimer’s disease,” said
Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business
Group, Eisai.
ADUHELM Poster Presentations
Item-level Analysis of Clinical Measures in Patients
with Early Symptomatic Alzheimer’s Disease Following Treatment with
High-dose Aducanumab in the Phase 3 Study EMERGE
A poster presentation about item-level data from the EMERGE
trial examines results on the individual items, or domains, that
comprised the study's pre-specified endpoints measuring cognition,
function and behavior. This analysis shows consistency of high-dose
aducanumab treatment effect across these individual items and
domains of the primary, secondary and tertiary clinical endpoints
in the Phase 3 trial.
In this data set from EMERGE, treatment effects were observed
across all six domains (three cognitive and three functional)
measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB), the
primary endpoint of the trial. Secondary endpoints of the trial
included change from baseline in the Alzheimer’s Disease Assessment
Scale – Cognitive Subscale (13 items) (ADAS-Cog13) and the
Alzheimer’s Disease Cooperative Study-Activities of Daily Living
Inventory (Mild Cognitive Impairment version) (ADCS-ADL-MCI).
Treatment effects were observed across ADAS-Cog13 items sensitive
to cognitive change in early symptomatic Alzheimer’s disease and
across a broad range of items measuring ability to conduct
activities of daily living, as measured by ADCS-ADL-MCI.
Treatment was also associated with a reduction in the behavioral
and psychiatric symptoms of Alzheimer’s disease, as measured by the
Neuropsychiatric Inventory-10 (NPI-10), the tertiary efficacy
endpoint of EMERGE.
These results are consistent with the results from the primary
analysis of these pre-specified endpoints in EMERGE, endpoints that
were selected to measure the broad array of cognitive, functional
and behavioral symptoms experienced by individuals with Alzheimer’s
disease. The analysis concludes that, in EMERGE, treatment with
high-dose aducanumab demonstrated reduced clinical decline
evidenced by a statistically significant treatment effect on
pre-specified primary and secondary clinical efficacy endpoints
compared to placebo.
Reductions in Biomarkers of Alzheimer’s Disease
Pathophysiology Following Treatment with Aducanumab Were Associated
with Slowing in Clinical Decline
A separate poster presentation examines whether an
aducanumab-induced reduction in brain amyloid beta (Aβ) plaques and
downstream biomarkers of Alzheimer’s disease pathophysiology are
associated with a slowing of clinical decline.
The authors assessed this through three analyses. The first, a
group-level analysis, examined the association between treatment
effect of aducanumab relative to placebo on brain Aβ plaque levels
and clinical decline, as measured by amyloid positron emission
tomography (PET) imaging and CDR-SB, respectively, across all
aducanumab dose groups in the PRIME, EMERGE and ENGAGE clinical
trials. Group-level analyses based on data from these trials
demonstrated a positive association between aducanumab treatment
effect on brain amyloid beta plaques and clinical measures across
dose groups and studies, with the exception of the high-dose group
from ENGAGE.
The second set of analyses assessed the relationship between
treatment effects of aducanumab on brain Aβ plaque levels,
downstream biomarkers of Alzheimer’s disease pathophysiology and
clinical measures in participant-level analyses. In EMERGE and
PRIME, a greater reduction in brain Aβ plaque levels was associated
with less decline across clinical endpoints in each study. In
EMERGE, greater reduction in brain Aβ plaque levels was also
associated with greater reduction in cerebrospinal fluid (CSF)
markers of tau and neurodegeneration as well as less decline on
clinical endpoints. Several of these relationships were not
apparent in ENGAGE, in which a clinical treatment effect of
aducanumab was not observed.
The third analysis showed that a smaller magnitude of clinical
decline was observed in patients in PRIME, EMERGE and ENGAGE whose
brain Aβ plaque levels were lowered to a threshold considered to be
amyloid negative relative to patients who did not reach this
threshold. Together, these results are consistent with the
hypothesized mechanism of action of aducanumab and support a
relationship between aducanumab-induced changes in biomarkers of
Alzheimer’s disease pathophysiology and slowing of clinical
decline.
Additional ADUHELM Poster Presentations
Biogen will present two additional virtual posters about
ADUHELM.
- “Subgroup Analyses of the Amyloid
PET Substudies from EMERGE and ENGAGE, Phase 3 Clinical Trials
Evaluating Aducanumab in Patients with Early Alzheimer’s Disease”
is a poster that examines how aducanumab affected brain Aβ plaque
levels in Alzheimer’s disease patients stratified into 13
pre-specified subgroups based on 6 baseline factors: ApoE ε4
status, baseline clinical stage (MCI due to Alzheimer’s disease or
mild Alzheimer’s disease dementia), baseline severity (MMSE),
baseline use of other approved Alzheimer’s disease therapies, age
and sex. In all 13 pre-specified subgroups, there was a
dose-dependent reduction in Aβ plaque levels relative to placebo
for patients in the low-dose and high-dose groups across both
EMERGE and ENGAGE, consistent with the results of the overall
amyloid PET substudy population.
- “Considerations for the real-world
management of ARIA from the aducanumab Phase 3 studies EMERGE and
ENGAGE” is a poster that describes the characteristics of Amyloid
Related Imaging Abnormalities (ARIA) that occurred in participants
treated with high-dose (10 mg/kg) aducanumab in EMERGE and ENGAGE,
in order to inform effective ARIA monitoring and management in
real-world clinical practice. Included in the poster are
data on ARIA incidence, radiographic severity and
symptoms in ApoE ε4 carriers and
noncarriers; timing of ARIA-E radiographic detection
and resolution; the relationship
between radiographic severity and symptoms; and
outcomes of dosing through mild, asymptomatic ARIA.
In the U.S., ARIA monitoring and management should be carried out
in accordance with the recommendations in the U.S. Prescribing
Information. The poster’s conclusions include:
- ARIA were mostly asymptomatic: 76%
of aducanumab-treated participants with ARIA showed no
symptoms.
- ARIA were generally mild or moderate
in radiographic severity and were transient.
- Radiographic severity and
symptomatic status were similar for ApoE Ꜫ4 carriers and
noncarriers.
- Radiographic severity of ARIA alone
is not predictive of symptomatic status.
- Radiographically severe ARIA-H was
generally concurrent with ARIA-E.
- New-onset symptoms were noted in
approximately 6 percent of ARIA events where dosing was
continued.
Posters and presentations will be available for 30 days on the
AAIC conference website. They will also be available on
Biogen.com.
About ADUHELM™ (aducanumab-avwa)
injection 100 mg/mL solutionADUHELM 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
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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: the
potential clinical effects of ADUHELM and BIIB080; the potential
benefits, safety and efficacy of ADUHELM and BIIB080; the results
of the Phase 3 studies and Phase 1b study of ADUHELM and the Phase
1b study of BIIB080; the identification and treatment of
Alzheimer’s disease; potential regulatory approvals and the timing
thereof; the potential of our commercial business and pipeline
programs, including ADUHELM and BIIB080; 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 BIIB080; 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: 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 and BIIB080; 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
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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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