Update on Regulatory Submission for Aducanumab in the European
Union
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
negative opinion on the Marketing Authorization Application (MAA)
for aducanumab for the treatment of the early stages of Alzheimer’s
disease known as mild cognitive impairment (MCI) due to Alzheimer’s
disease and mild Alzheimer’s disease dementia. This decision is
aligned to the negative trend vote of the committee in November
2021. Biogen will seek a re-examination of the opinion by the CHMP.
“For Europeans impacted by Alzheimer’s disease, the lack of
options to treat its early stages is felt every day. The longer we
wait, the more people will progress toward more advanced dementia
and we may miss the opportunity to potentially treat them,” said
Priya Singhal, M.D., M.P.H., Head of Global Safety & Regulatory
Sciences and interim Head of Research & Development at Biogen.
“As part of the re-examination process, we will seek to address the
CHMP’s grounds for refusal, with the goal of making this medicine
available in the EU. European patients deserve access to innovative
treatments for Alzheimer’s disease.”
The European Commission’s regulations1 allow an applicant to
request a re-examination of a CHMP opinion, followed by submission
of documentation with detailed grounds for the request. The
Committee has 60 days after receipt of this documentation to
re-examine their opinion2.
The MAA included efficacy, safety and biomarker data from a
global, multi-study clinical development program which included
approximately 3,600 patients in more than 20 countries.
In June 2021, the U.S. Food and Drug Administration (FDA)
granted accelerated approval for ADUHELM® (aducanumab-avwa) 100
mg/mL injection for intravenous use as the first Alzheimer’s
disease treatment to address a defining pathology of the disease by
reducing amyloid beta plaques in the brain. ADUHELM is also
approved in the United Arab Emirates (UAE).
About
ADUHELM® (aducanumab-avwa)
injection 100 mg/mL solution for intravenous useIn the
United States, 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).
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.
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 U.S. full Prescribing Information,
including Medication Guide, for ADUHELM.
About Alzheimer’s DiseaseAlzheimer’s disease is
a progressive neurological condition that impairs thinking, memory
and independence, leading to premature death. The disease is a
growing global health crisis, affecting those living with the
disease and their families. According to the World Health
Organization (WHO), more than 30 million people worldwide live with
Alzheimer’s disease, and the number will grow in the years ahead,
outpacing the healthcare resources needed to manage it and costing
billions of dollars.
Alzheimer’s disease is characterized by changes in the brain,
including the abnormal accumulation of toxic amyloid beta plaques,
which begins approximately 20 years before patients exhibit
symptoms of the disease. Mild cognitive impairment due to
Alzheimer’s disease is one of the earliest symptomatic stages of
the disease when symptoms start to be more visible and can be
detected and diagnosed.For more information about Alzheimer’s
disease, visit www.ItsTimeWeKnow.com.
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, 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
CONTACT(S):BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR
CONTACT(S):BiogenMike Hencke+1 781 464
2442IR@biogen.com |
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Eisai Co., Ltd.
Public Relations Department TEL : +81 (0)3 3817
5120 |
Eisai Co.,
Ltd. Investor Relations Department TEL:
+81-(0)70-8688-9685 |
__________________________
1 EC guideline: REGULATION (EC) No 726/2004 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 31 March 2004
(https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF)2
European Medicines Agency, Procedural Advice on the Re-Examination
of CHMP Opinions, 2009.
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-re-examination-chmp-opinions_en.pdf
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