Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today
announced that the U.S. Food and Drug Administration (FDA) has
granted accelerated approval for ADUHELM™ (aducanumab-avwa) as the
first and only Alzheimer’s disease treatment to address a defining
pathology of the disease by reducing amyloid beta plaques in the
brain.
The accelerated approval has been granted based on data from
clinical trials demonstrating the effect of ADUHELM on reducing
amyloid beta plaques, a biomarker that is reasonably likely to
predict clinical benefit, in this case a reduction in clinical
decline. Continued approval for ADUHELM’s indication as a treatment
for Alzheimer’s disease may be contingent upon verification of
clinical benefit in confirmatory trial(s).
“This historic moment is the culmination of more than a decade
of groundbreaking research in the complex field of Alzheimer’s
disease. We believe this first-in-class medicine will transform the
treatment of people living with Alzheimer’s disease and spark
continuous innovation in the years to come,” said Michel Vounatsos,
Chief Executive Officer at Biogen. “We are grateful for the
contributions of thousands of patients and caregivers who
participated in our clinical trials, as well as for the dedication
of our scientists and researchers. Together with the healthcare
community, we are ready to bring this new medicine to patients and
begin to address this growing global health crisis.”
“Eisai has been working on the creation of new treatments for
Alzheimer’s disease since the early 80s through our relentless
pursuit to understand the root causes of this disease, and we have
spent more than a quarter of a century with people living with
Alzheimer’s disease to understand their needs,” said Haruo Naito,
Chief Executive Officer at Eisai. “We are very pleased to be able
to open a new chapter in the history of Alzheimer’s disease
treatment with the approval of ADUHELM. This approval has the
potential to bring hope to the future of global health, society
and, most importantly, the patients and their families, and
represents a great step toward the advancement of holistic
ecosystem solutions for this devastating disease.”
The efficacy of ADUHELM was evaluated in two Phase 3 clinical
trials—EMERGE (Study 1) and ENGAGE (Study 2)—in patients with early
stages of Alzheimer’s disease (mild cognitive impairment and mild
dementia) with confirmed presence of amyloid pathology. The effects
of ADUHELM were also assessed in the double-blind, randomized,
placebo-controlled, dose-ranging Phase 1b study, PRIME (Study 3).
In these studies, ADUHELM consistently showed a dose- and
time-dependent effect on the lowering of amyloid beta plaques (by
59 percent [p<0.0001] in ENGAGE, 71 percent [p<0.0001] in
EMERGE, and 61 percent [p<0.0001] in PRIME).
The ADUHELM safety profile is well characterized in over 3,000
patients who received at least one dose of ADUHELM. The most
frequently reported adverse event was radiographic detection of
events termed Amyloid Related Imaging Abnormalities, or “ARIA.”
ARIA (-E and/or -H) was observed in 41 percent of patients treated
with ADUHELM 10 mg/kg compared to 10 percent of patients on
placebo. Clinical symptoms were present in 24 percent of patients
treated with ADUHELM 10 mg/kg who had an observation of ARIA (-E
and/or -H), compared to 5 percent of patients on placebo. The most
common symptom in patients with ARIA was headache. Other symptoms
associated with ARIA included confusion, dizziness, visual
disturbances, and nausea. Adverse reactions that were reported in
at least 2 percent of patients treated with ADUHELM and at least 2
percent more frequently than in patients on placebo were ARIA-E,
headache, ARIA-H microhemorrhage, ARIA-H superficial siderosis,
fall, diarrhea, and confusion/delirium/altered mental
status/disorientation.
As part of the accelerated approval, Biogen will conduct a
controlled trial to verify the clinical benefit of ADUHELM in
patients with Alzheimer’s disease.
Dr. Stephen Salloway, Director of Neurology and the Memory and
Aging Program at Butler Hospital, said, “This approval represents a
major advance in the treatment of Alzheimer’s disease. By reducing
amyloid beta plaques in the brain, we are addressing one of the
defining pathologies of the disease. People with Alzheimer’s
disease, together with their doctors, can now decide if the
treatment is right for them.”
“Today’s approval of ADUHELM is a transformational breakthrough
in the fight to stop this horrible disease. After years of
disappointment and despair, this decision offers new hope for many
families and a trigger for future investment and innovation,” said
George Vradenburg, Chairman and Co-Founder of UsAgainstAlzheimer’s.
“Because ADUHELM was studied in people with early-stage Alzheimer’s
disease, it will be important for our nation’s healthcare
system—patients, providers and payers—to be ready for earlier
detection, diagnosis and intervention in the treatment of the
disease.”
Note to Editors: More information about the launch of ADUHELM in
the U.S. is available here.
Investor Webcast
InformationBiogen will host a live webcast to
discuss the approval of ADUHELM on June 8, 2021 at 8:00 a.m. ET. To
access the webcast, please go to the Investors section of Biogen’s
website at investors.biogen.com. An archived version of the webcast
will be available following the presentation.
INDICATION and IMPORTANT SAFETY INFORMATION
INDICATION ADUHELM is a prescription medicine
used to treat people with Alzheimer’s disease.
IMPORTANT SAFETY INFORMATION What is
the most important information a patient should know about
ADUHELM? 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. It is most
commonly seen as temporary swelling in areas of the brain that
usually resolves over time. Some people may also have small spots
of bleeding in or on the surface of the brain with the swelling.
Although most people with swelling in areas of the brain 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.
Patients should call their healthcare provider or go to the
nearest hospital emergency room right away if they have any of the
symptoms listed above.
Before receiving ADUHELM, patients should tell their
healthcare provider about all of their medical conditions,
including if: they are pregnant or plan to become pregnant
or are breastfeeding or plan to breastfeed. It is not known if
ADUHELM will harm their unborn baby or if aducanumab-avwa (the
active ingredient in ADUHELM) passes into breast milk.
What are the possible side effects of ADUHELM? ADUHELM
can cause serious side effects, including: See above “What is the
most important information a patient should know about
ADUHELM?”
Serious allergic reactions. Swelling of the
face, lips, mouth, or tongue and hives have happened during an
ADUHELM infusion. Patients should tell their healthcare provider if
they have any of the symptoms of a serious allergic reaction during
or after an ADUHELM infusion.
The most common side effects of ADUHELM include: swelling in
areas of the brain, with or without small spots of bleeding in or
on the surface of the brain (ARIA); headache and fall. Patients
should call their healthcare provider for medical advice about side
effects. Patients may report side effects to FDA at
1-800-FDA-1088.
Please see full Prescribing
Information including Medication
Guide.
About ADUHELM (aducanumab-avwa)
ADUHELM (aducanumab-avwa), a human monoclonal antibody, is the
first and only Alzheimer’s disease treatment to address a defining
pathology of the disease by reducing amyloid beta plaques in the
brain. ADUHELM is indicated for the treatment of Alzheimer’s
disease. This indication is granted under accelerated approval
based on reduction in amyloid beta plaques in patients treated
with ADUHELM. Continued approval for this indication may be
contingent upon verification of clinical benefit in
confirmatory trial(s).
Biogen licensed ADUHELM from Neurimmune in 2007 under a
collaborative development and license agreement. Since October
2017, Biogen and Eisai have collaborated on the development and
commercialization of ADUHELM globally.
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 and pipeline programs, including
ADUHELM; the potential clinical effects of ADUHELM; the potential
benefits, safety and efficacy of ADUHELM; planning and timing for
the commercial launch of, and access to, ADUHELM; anticipated
manufacturing, distribution and supply of ADUHELM; the treatment of
Alzheimer’s disease; the anticipated benefits and potential of our
collaboration arrangements with Eisai; clinical development
programs, clinical trials and data readouts and presentations; 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: uncertainty of success in the
development and commercialization of ADUHELM; risks relating to the
launch of ADUHELM, including preparedness of healthcare providers
to treat patients, the ability to obtain and maintain adequate
reimbursement for ADUHELM and other unexpected difficulties or
hurdles; regulatory submissions may take longer or be more
difficult to complete 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; risks relating to investment in our manufacturing
capacity; problems with our manufacturing processes; 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;
risks associated with current and potential future healthcare
reforms; risks relating to the distribution and sale by third
parties of counterfeit or unfit versions of our products; 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
we have 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.Anna
Robinson+1-781-464-3260public.affairs@biogen.comINVESTOR
CONTACT:Biogen Inc.Mike Hencke+1-781-464-2442IR@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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