Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3
EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s
Disease
Biogen Inc. (Nasdaq: BIIB) announced that The Journal of
Prevention of Alzheimer’s Disease (JPAD) today published a
peer-reviewed manuscript detailing data from the pivotal Phase 3
EMERGE and ENGAGE trials for ADUHELM® (aducanumab-avwa) 100
mg/mL injection for intravenous use in early Alzheimer’s disease.
The publication includes results from the primary, secondary and
tertiary endpoints in the trials, as well as safety data and
biomarker sub-studies.
In June 2021, the U.S. Food and Drug Administration (FDA)
granted accelerated approval for ADUHELM as the first Alzheimer’s
disease treatment to address a defining pathology of the disease.
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).
“We are pleased that the peer-reviewed manuscript is now
available to provide physicians with a greater understanding of the
appropriate use of ADUHELM,” said Samantha Budd Haeberlein, Ph.D.,
SVP, Head of Neurodegeneration Development at Biogen. “We will
continue to provide physicians with efficacy and safety data to
help them make the best treatment decisions for patients as we
learn from our ongoing trials and real-world evidence.”
“The peer reviewed publication of these data is a testament to
the importance of the findings for the scientific and Alzheimer’s
disease communities,” said Dr. Paul Aisen, MD., Alzheimer
Therapeutic Research Institute, University of Southern California,
San Diego. “Alzheimer’s disease is an incredibly complex condition,
and this dataset is critical to advancing the understanding of the
Phase 3 results.”
The publication may be accessed on the JPAD’s website, here.
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.
From 2017 to March 13, 2022, Biogen and Eisai jointly
collaborated on the development, commercialization and
manufacturing of ADUHELM. Effective March 14, 2022, Biogen has sole
decision-making authority over the development, commercialization
and manufacturing of ADUHELM. In 2022 the parties will continue in
a global profit/loss sharing arrangement subject to a cap on
Eisai’s expenses for 2022. Eisai will be entitled to a tiered
royalty on net sales of ADUHELM as of January 1, 2023.
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
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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;
the treatment of Alzheimer’s disease; the anticipated benefits and
potential of Biogen’s collaboration arrangements with Eisai;
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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
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foregoing sets forth many, but not all, of the factors that could
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