Long-Term Phase 3 Data Show ADUHELM® Continues to Reduce Underlying
Pathologies of Alzheimer’s Disease in Patients Treated for More
Than Two Years
Biogen Inc. (Nasdaq: BIIB) announced new data showing that
after nearly two and a half years of treatment (128 weeks) with
ADUHELM® (aducanumab-avwa) injection 100 mg/mL for intravenous use,
patients in the long-term extension phase of the Phase 3 trials
continued to experience significant reductions in two key
Alzheimer’s disease pathologies, amyloid beta plaques and plasma
p-tau181. The data also show that in both Phase 3 trials, at 78
weeks, patients with reduced levels of plasma p-tau181 had less
clinical decline than those whose plasma p-tau181 levels were not
reduced.
Data from the long-term extension study showed that ADUHELM
significantly reduced amyloid beta plaque levels out to Week
132. The data also showed that ADUHELM continued to decrease
plasma p-tau181 levels at 128 weeks. Patients with more effective
amyloid beta clearance (SUVR lower than 1.1 by 78 weeks) also had
greater decreases in p-tau181 at week 128. These findings point to
the potential of continued benefit of treatment in the longer term
with continued reduction of amyloid beta plaques.
“These are meaningful findings, which further our understanding
of amyloid and downstream biomarkers, such as p-tau 181, in
Alzheimer’s disease and can help inform how long patients may
benefit from treatment to reduce amyloid beta plaque,” said
Samantha Budd Haeberlein, Ph.D., SVP, Head of Neurodegeneration
Development at Biogen. “These data demonstrate that long-term
treatment with ADUHELM continues to reduce the underlying
pathologies of Alzheimer’s disease beyond two years."
Data showed that patients with a reduction in plasma p-tau181,
an exploratory endpoint, had less clinical progression across all
four clinical endpoints (CDR-SB, MMSE, ADAS-Cog13, and
ADCS-ADL-MCI) measuring cognition and function in both Phase 3
trials at Week 78.
In the placebo-controlled period of the Phase 3 trials, the
incidence of ARIA-E in the 10 mg/kg group was 35.2%. The incidence
was higher among APOE ε4 carriers (43.0%) than non-carriers
(20.3%). While the majority of ARIA is asymptomatic, serious
symptoms in the setting of ARIA can occur (0.3% of participants in
the 10 mg/kg group of the Phase 3 trials. Most events (98.2%) of
ARIA-E resolved on study, with the majority resolving within 12-16
weeks. Biogen is committed to continuing to work with the aim that
ARIA is further characterized and that the risk of ARIA is well
understood.
An archived version of the presentation is available on the
investors section of Biogen’s website at investors.biogen.com.
The long-term Phase 3 extension study was presented today at the
International Conference on Alzheimer’s and Parkinson’s Diseases
(AD/PD 2022), currently underway in Barcelona, Spain, and virtually
from March 15-20.
These latest data are part of Biogen’s ongoing commitment to
generate additional clinical data to further characterize and
understand ADUHELM’s profile and engage with the scientific
community. Additional research data was presented at AD/PD, along
with multiple presentations describing various aspects of ADUHELM’s
clinical program.
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 Biogen
As 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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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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