Update on Regulatory Review of Aducanumab in the European Union
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan)
announced today an update on the ongoing review of the Marketing
Authorization Application for aducanumab 100 mg/mL concentrate
solution for infusion for the treatment of Alzheimer’s disease by
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA).
Following an oral explanation held at the November meeting of
the CHMP, Biogen received a negative trend vote on the aducanumab
Marketing Authorization Application. The CHMP is expected to adopt
a formal opinion on the Marketing Authorization Application at its
December meeting (December 13-16, 2021). Biogen will continue to
engage with the EMA and CHMP as it considers next steps towards the
goal of providing access to aducanumab to patients in Europe.
“While we are disappointed with the trend vote, we strongly
believe in the strength of our data and that aducanumab has the
potential to make a positive and meaningful difference for people
and families affected by Alzheimer’s disease,” said Priya Singhal,
M.D., M.P.H., Head of Global Safety & Regulatory Sciences and
interim Head of Research & Development at Biogen.
At the recent Clinical Trials on Alzheimer’s Disease conference
(CTAD), Biogen announced new Phase 3 findings that provide further
evidence of aducanumab’s effect on lowering amyloid beta plaque and
downstream tau pathology, the two defining pathologies of
Alzheimer’s disease.
About ADUHELM™ (aducanumab-avwa)
injection 100 mg/mL solutionADUHELM is indicated for the
treatment of Alzheimer’s disease in the United States. 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 in the United States 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.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating
on the global co-development and co-promotion of aducanumab.
Please click here for US 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 the
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
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 potential regulatory discussions,
submissions and approvals and the timing thereof, the potential
clinical effects of ADUHELM; the potential benefits, safety and
efficacy of ADUHELM; 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; anticipated manufacturing,
distribution, and supply of ADUHELM; the treatment of Alzheimer’s
disease; the anticipated benefits and potential of Biogen’s
collaboration arrangements with Eisai; the potential of Biogen’s
commercial business and pipeline programs, including ADUHELM; 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; unexpected concerns that may arise from
additional data or analysis obtained during clinical trials; the
occurrence of adverse safety events, restrictions on use, or
product liability claims; 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; 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; and the
direct and indirect impacts of the ongoing COVID-19 pandemic on our
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.
MEDIA
CONTACTS:BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR CONTACTS:BiogenMike
Hencke+1 781 464 2442IR@biogen.com |
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Department TEL : +1 201 753 1945 Eisai Co., Ltd.
(Media Outside the U.S.) Public Relations
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