Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today
announced the U.S. Food and Drug Administration (FDA) has approved
an updated label for ADUHELM™ (aducanumab-avwa) injection 100 mg/mL
solution.
The update includes an addition to the Indications and Usage
section of the label (Section 1) to emphasize the disease stages
studied in the clinical trials, as seen below (italics to note
updated language).
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).
Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and
Development at Biogen, said, “Based on our ongoing conversations
with prescribing physicians, FDA and patient advocates, we
submitted this label update with the goal to further clarify the
patient population that was studied across the three ADUHELM
clinical trials that supported approval. We are committed to
continue to listen to the community’s needs as clinical practice
adapts to this important, first-in-class treatment option.”
The update clarifies the indication by emphasizing information
about the disease stages studied in the ADUHELM clinical trials.
Information about the population studied has been previously
communicated by Biogen and Eisai, including in the companies’
statement of June 23, 2021.
Please see the full Prescribing
Information.
INDICATION and IMPORTANT SAFETY INFORMATION
INDICATION
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).
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 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, about Biogen’s
strategy and plans; potential of, and expectations for, Biogen’s
commercial business and pipeline programs, including ADUHELM;
planning and timing for the commercial launch of, and access to,
ADUHELM; 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; clinical
development programs, clinical trials and data readouts and
presentations; and risks and uncertainties associated with drug
development and commercialization. These statements may be
identified by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“possible,” “potential,” “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 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 Biogen’s drug
candidates, including ADUHELM; 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 property
and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; risks associated with
current and potential future healthcare reforms; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
business, results of operations and financial condition. The
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
reports Biogen has 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.Allison
Parks+ 248 229 4461public.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)3-3817-5327 |
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