FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for
the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”)
and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,
Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced
today that the U.S. Food and Drug Administration (FDA) has approved
the supplemental Biologics License Application (sBLA) supporting
the traditional approval of LEQEMBI
®
(lecanemab-irmb) 100 mg/mL injection for intravenous use, making
LEQEMBI the first and only approved treatment shown to reduce the
rate of disease progression and to slow cognitive and functional
decline in adults with Alzheimer’s disease (AD). LEQEMBI
demonstrated clinically meaningful slowing of cognitive and
functional decline in a patient group generalizable to U.S.
Medicare beneficiaries, which included a mix of racial and ethnic
groups, patients with common comorbid conditions, concomitant
medications and patients with mild cognitive impairment (MCI) due
to AD or mild AD. Treatment with LEQEMBI should be initiated in
patients with MCI or mild dementia stage of disease, (collectively
referred to as early AD) the population in which treatment was
initiated in clinical trials.
LEQEMBI’s traditional approval is based on Phase
3 data from Eisai’s large, global Clarity AD clinical trial, in
which LEQEMBI met its primary endpoint and all key secondary
endpoints with statistically significant results and confirmed the
clinical benefit of LEQEMBI. The primary endpoint was the global
cognitive and functional scale, Clinical Dementia Rating Sum of
Boxes (CDR-SB). LEQEMBI treatment reduced clinical decline on
CDR-SB by 27% at 18 months compared to placebo. Additionally, the
secondary endpoint of AD Cooperative Study-Activities of Daily
Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), as
measured by people caring for patients with AD, noted a
statistically significant benefit of 37%. This measures the ability
of patients to function independently, including being able to
dress, feed themselves and participate in community activities.
Full results of the Clarity AD study were presented at the Clinical
Trials on Alzheimer's Disease (CTAD) 2022 conference and
simultaneously published in the peer-reviewed medical journal The
New England Journal of Medicine on November 29, 2022.
Importantly, following FDA’s traditional
approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI
is now available and released more details on the registry,
including the easy-to-use data submission process. The
CMS-facilitated registry is now available for healthcare
professionals to submit required patient data to CMS. Eisai is
pleased that Medicare will cover this important therapy for
appropriate patients. This will facilitate reimbursement for and
access to LEQEMBI across a broad range of healthcare settings in
the United States.
“Today, the FDA approved LEQEMBI under the
traditional approval pathway, making LEQEMBI the first and only
approved anti-amyloid Alzheimer's disease treatment shown to reduce
the rate of disease progression and to slow cognitive impairment in
the early and mild dementia stages of the disease. As a research
and development-focused company based on our hhc (human health
care) concept, we are proud that the results of Eisai's AD research
over the past 40 years have been recognized and delivered to people
living with this disease in the United States,” said Haruo Naito,
Chief Executive Officer at Eisai. “Alzheimer’s disease is a
progressive, fatal disease that greatly impacts not only the people
living with it, but also their loved ones, care partners and
society. We continue to work to create broad and simple access to
LEQEMBI for patients and to support diagnosis and treatment at the
early stage of the disease. Eisai will diligently work to educate
physicians on the safe and appropriate use of LEQEMBI to maximize
its benefit to people living with early AD and their families.”
“Today marks a breakthrough in the treatment of Alzheimer’s
disease, and we are proud to be at the forefront of ushering in a
new era of advances for a disease that was previously considered
untreatable. We would like to express our sincere appreciation to
those who have worked tirelessly to find a treatment for this
unrelenting disease, without whom this progress would not be
possible,” said Christopher A. Viehbacher, President and Chief
Executive Officer of Biogen. "Our focus is now on the path forward,
working alongside Eisai with the goal of making LEQEMBI accessible
to eligible patients as soon as possible.”
LEQEMBI is a humanized immunoglobulin gamma 1
(IgG1) monoclonal antibody directed against aggregated soluble
(protofibril*) and insoluble forms of amyloid beta (Aβ).
Critically, LEQEMBI targets and clears the most neurotoxic form of
Aβ that continuously accumulates as well as removes the existing
plaques to treat this progressive, chronic disease. In June 2023,
the FDA’s Peripheral and Central Nervous System Drugs (PCNS)
advisory committee voted unanimously that the data from Eisai’s
Clarity AD clinical trial confirmed the clinical benefit of LEQEMBI
for the treatment of AD. Committee members also confirmed the
overall risk-benefit of LEQEMBI. On January 6, 2023, LEQEMBI was
approved by the FDA under the accelerated approval pathway.
Eisai has developed and deployed Understanding
ARIA™, a multi-faceted educational initiative to further advance
understanding in the AD healthcare community of the real-world
management and monitoring of amyloid-related imaging abnormalities
(ARIA). In collaboration with experts in the field of medical
imaging as well as major professional societies, Understanding
ARIA™ offers resources and programs that include peer-to-peer
education, individual and group educational sessions and
subject-matter-expert evaluation of historical case studies.
Eisai is committed to ensuring that appropriate
patients have access to LEQEMBI and has established a Patient
Assistance Program to provide LEQEMBI at no cost, for eligible
uninsured and underinsured patients, including Medicare
beneficiaries, who meet financial need and other program criteria.
Additionally, Eisai offers patient support for improving access
through LEQEMBI Patient Navigators, who will provide information
about accessing LEQEMBI, help patients and their families
understand their insurance coverage and options, and identify
financial support programs for eligible patients. People in the
U.S. can learn more about these services by visiting LEQEMBI.com,
calling 1-833-4-LEQEMBI (1-833-453-7362), Monday-Friday, 8 a.m. to
8 p.m. Eastern Time or faxing an enrollment form to
1-833-770-7017.
Eisai serves as the lead of LEQEMBI development
and regulatory submissions globally with both Eisai and Biogen
co-commercializing and co-promoting the product and Eisai having
final decision-making authority.
*Protofibrils are large Aβ aggregated soluble
species of 75-5000 Kd.2,3.4
INDICATIONLEQEMBI is indicated for the
treatment of Alzheimer’s disease. Treatment with LEQEMBI 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.
IMPORTANT SAFETY INFORMATION
WARNING: AMYLOID RELATED IMAGING ABNORMALITIES
(ARIA)
- Monoclonal antibodies directed
against aggregated forms of amyloid beta, including LEQEMBI, can
cause amyloid related imaging abnormalities (ARIA), characterized
as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition
(ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA
usually occurs early in treatment and is usually
asymptomatic, although serious
and life-threatening events rarely can occur. Serious
intracerebral hemorrhages >1 cm, some of which have been fatal,
have been observed in patients treated with this class of
medications.
- Apolipoprotein E ε4 (ApoE ε4)
Homozygotes: Patients who are ApoE ε4 homozygotes
(approximately 15% of Alzheimer’s disease patients) treated with
this class of medications, including LEQEMBI, have a higher
incidence of ARIA, including symptomatic, serious, and severe
radiographic ARIA, compared to heterozygotes and noncarriers.
Testing for ApoE ε4 status should be performed prior to initiation
of treatment to inform the risk of developing ARIA. Prior to
testing, prescribers should discuss with patients the risk of ARIA
across genotypes and the implications of genetic testing results.
Prescribers should inform patients that if
genotype testing is not performed, they can still be treated with
LEQEMBI; however, it cannot be determined if they are
ApoE ε4 homozygotes and at higher risk for
ARIA.
- Consider the benefit of
LEQEMBI for the treatment of Alzheimer’s disease and potential risk
of serious adverse events associated with ARIA when deciding to
initiate treatment with LEQEMBI
|
CONTRAINDICATION
LEQEMBI is contraindicated in patients with serious
hypersensitivity to lecanemab-irmb or to any of the excipients of
LEQEMBI. Reactions have included angioedema and
anaphylaxis.
WARNINGS AND PRECAUTIONS
AMYLOID RELATED IMAGING ABNORMALITIES
- LEQEMBI can cause ARIA-E and ARIA-H. ARIA-E can be observed on
MRI as brain edema or sulcal effusions, and ARIA-H as
microhemorrhage and superficial siderosis. ARIA can occur
spontaneously in patients with Alzheimer’s disease. ARIA-H
associated with monoclonal antibodies directed against aggregated
forms of beta amyloid generally occurs in association with an
occurrence of ARIA-E. ARIA-H and ARIA-E can occur together. ARIA
usually occurs early in treatment and is usually asymptomatic,
although serious and life-threatening events, including seizure and
status epilepticus, rarely can occur. Reported symptoms associated
with ARIA may include headache, confusion, visual changes,
dizziness, nausea, and gait difficulty. Focal neurologic deficits
may also occur. Symptoms associated with ARIA usually resolve over
time.
ARIA Monitoring and Dose Management
Guidelines
- Obtain recent baseline brain magnetic resonance imaging (MRI)
prior to initiating treatment with LEQEMBI. Obtain an MRI prior to
the 5th, 7th and 14th infusions.
- Recommendations for dosing in patients with ARIA-E and ARIA-H
depend on clinical symptoms and radiographic severity. Depending on
ARIA severity, use clinical judgment in considering whether to
continue dosing, temporarily discontinue treatment, or permanently
discontinue LEQEMBI.
- Enhanced clinical vigilance for ARIA is recommended during the
first 14 weeks of treatment with LEQEMBI. If a patient experiences
symptoms suggestive of ARIA, clinical evaluation should be
performed, including MRI if indicated. If ARIA is observed on MRI,
careful clinical evaluation should be performed prior to continuing
treatment.
- There is no experience in patients who continued dosing through
symptomatic ARIA-E or through asymptomatic, but radiographically
severe, ARIA-E. There is limited experience in patients who
continued dosing through asymptomatic but radiographically mild to
moderate ARIA-E. There are limited data in dosing patients who
experienced recurrent ARIA-E.
Incidence of ARIA
- In Study 2, symptomatic ARIA occurred in 3% (29/898) of
LEQEMBI-treated patients. Serious symptoms associated with ARIA
were reported in 0.7% (6/898) of patients treated with LEQEMBI.
Clinical symptoms associated with ARIA resolved in 79% (23/29) of
patients during the period of observation.
- Including asymptomatic radiographic events, ARIA was observed
in LEQEMBI: 21% (191/898); placebo: 9% (84/897). ARIA-E was
observed in LEQEMBI: 13% (113/898); placebo: 2% (15/897). ARIA-H
was observed in LEQEMBI: 17% (152/898); placebo: 9% (80/897). There
was no increase in isolated ARIA-H for LEQEMBI vs placebo.
ApoE ε4 Carrier Status and Risk of ARIA
- In Study 2, 16% (141/898) of patients in the LEQEMBI arm were
ApoE ε4 homozygotes, 53% (479/898) were heterozygotes, and 31%
(278/898) were noncarriers.
- The incidence of ARIA was higher in ApoE ε4 homozygotes
(LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%;
placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Among
patients treated with LEQEMBI, symptomatic ARIA-E occurred in 9% of
ApoE ε4 homozygotes compared with 2% of heterozygotes and 1%
noncarriers. Serious events of ARIA occurred in 3% of ApoE ε4
homozygotes, and approximately 1% of heterozygotes and
noncarriers.
- The recommendations on management of ARIA do not differ between
ApoE ε4 carriers and noncarriers.
Radiographic
Findings
- The majority of ARIA-E radiographic events occurred early in
treatment (within the first 7 doses), although ARIA can occur at
any time and patients can have more than 1 episode. The maximum
radiographic severity of ARIA-E in patients treated with LEQEMBI
was mild in 4% (37/898), moderate in 7% (66/898), and severe in 1%
(9/898). Resolution on MRI occurred in 52% of ARIA-E patients by 12
weeks, 81% by 17 weeks, and 100% overall after detection. The
maximum radiographic severity of ARIA-H microhemorrhage in
LEQEMBI-treated patients was mild in 9% (79/898), moderate in 2%
(19/898), and severe in 3% (28/898) of patients; superficial
siderosis was mild in 4% (38/898), moderate in 1% (8/898) , and
severe in 0.4% (4/898). Among LEQEMBI-treated patients, the rate of
severe radiographic ARIA-E was highest in ApoE ε4 homozygotes 5%
(7/141), compared to heterozygotes 0.4% (2/479) or noncarriers 0%
(0/278). Among LEQEMBI-treated patients, the rate of severe
radiographic ARIA-H was highest in ApoE ε4 homozygotes 13.5%
(19/141), compared to heterozygotes 2.1% (10/479) or noncarriers
1.1% (3/278).
Intracerebral Hemorrhage
- Intracerebral hemorrhage >1 cm in diameter was reported in
0.7% (6/898) of patients in Study 2 after treatment with LEQEMBI
compared to 0.1% (1/897) on placebo. Fatal events of intracerebral
hemorrhage in patients taking LEQEMBI have been reported.
Concomitant Antithrombotic Medication:
- In Study 2, baseline use of antithrombotic medication (aspirin,
other antiplatelets, or anticoagulants) was allowed if the patient
was on a stable dose. The majority of exposures to antithrombotic
medications were to aspirin. Antithrombotic medications did not
increase the risk of ARIA with LEQEMBI. The incidence of
intracerebral hemorrhage was 0.9% (3/328 patients) in patients
taking LEQEMBI with a concomitant antithrombotic medication at the
time of the event compared to 0.6% (3/545 patients) in those who
did not receive an antithrombotic. Patients taking LEQEMBI with an
anticoagulant alone or combined with an antiplatelet medication or
aspirin had an incidence of intracerebral hemorrhage of 2.5% (2/79
patients) compared to none in patients who received placebo.
- Because intracerebral hemorrhages >1 cm in diameter have
been observed in patients taking LEQEMBI, additional caution should
be exercised when considering the administration of anticoagulants
or a thrombolytic agent (e.g., tissue plasminogen activator) to a
patient already being treated with LEQEMBI.
Other Risk Factors for Intracerebral
Hemorrhage:
- Patients were excluded from enrollment in Study 2 for findings
on neuroimaging that indicated an increased risk for intracerebral
hemorrhage. These included findings suggestive of cerebral amyloid
angiopathy (prior cerebral hemorrhage >1 cm in greatest
diameter, >4 microhemorrhages, superficial siderosis, vasogenic
edema) or other lesions (aneurysm, vascular malformation) that
could potentially increase the risk of intracerebral hemorrhage.
The presence of an ApoE ε4 allele is also associated with cerebral
amyloid angiopathy, which has an increased risk for intracerebral
hemorrhage. Caution should be exercised when considering the use of
LEQEMBI in patients with factors that indicate an increased risk
for intracerebral hemorrhage and in particular for patients who
need to be on anticoagulant therapy.
HYPERSENSITIVITY REACTIONSHypersensitivity
reactions, including angioedema, bronchospasm, and anaphylaxis,
have occurred in LEQEMBI-treated patients. Promptly discontinue the
infusion upon the first observation of any signs or symptoms
consistent with a hypersensitivity reaction, and initiate
appropriate therapy.
INFUSION-RELATED REACTIONS
- In Study 2, infusion-related reactions were observed in
LEQEMBI: 26% (237/898); placebo: 7% (66/897), and the majority of
cases in LEQEMBI-treated patients (75%, 178/237) occurred with the
first infusion. Infusion-related reactions were mostly mild (69%)
or moderate (28%) in severity. Infusion-related reactions resulted
in discontinuations in 1% (12/898) of LEQEMBI-treated patients.
Symptoms of infusion-related reactions included fever and flu-like
symptoms (chills, generalized aches, feeling shaky, and joint
pain), nausea, vomiting, hypotension, hypertension, and oxygen
desaturation.
- In the event of an infusion-related reaction, the infusion rate
may be reduced, or the infusion may be discontinued, and
appropriate therapy initiated as clinically indicated. Prophylactic
treatment with antihistamines, acetaminophen, nonsteroidal
anti-inflammatory drugs, or corticosteroids prior to future
infusions may be considered.
ADVERSE REACTIONS
- In Study 2, the most common adverse reactions leading to
discontinuation of LEQEMBI was ARIA-H microhemorrhages that led to
discontinuation in 2% (15/898) of patients treated with LEQEMBI
compared to <1% (1/897) of patients on placebo.
- In Study 2, the most common adverse reactions reported in ≥5%
of patients treated with LEQEMBI (N=898) and ≥2% higher than
placebo (N=897) were infusion-related reactions (LEQEMBI: 26%;
placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI:
13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%),
superficial siderosis of central nervous system (LEQEMBI: 6%;
placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting
(LEQEMBI: 6%; placebo: 4%).
Please see full Prescribing
Information for LEQEMBI, including Boxed
WARNING.
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Eisai Inc. (U.S.) |
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Libby Holman |
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Eisai Europe, Ltd. |
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Investor Contacts: |
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Eisai Co., Ltd. |
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Notes to Editors
1. About
LEQEMBI®
(lecanemab-irmb)LEQEMBI® (lecanemab-irmb) is the
result of a strategic research alliance between Eisai and
BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1)
monoclonal antibody directed against aggregated soluble
(protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is
an amyloid beta-directed antibody indicated as a disease-modifying
treatment for Alzheimer’s disease (AD) in the U.S. The U.S. Food
and Drug Administration (FDA) granted LEQEMBI accelerated approval
on January 6, 2023, and Traditional Approval on July 6, 2023.
Treatment with LEQEMBI 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.
Eisai has also submitted applications for
approval of lecanemab in Japan, EU, China, Canada, Great Britain
and South Korea. In Japan and China, the applications have been
designated for priority review, and in Great Britain, lecanemab has
been designated for the Innovative Licensing and Access Pathway
(ILAP), which aims to reduce the time to market for innovative
medicines.
Eisai has completed a lecanemab subcutaneous
bioavailability study, and subcutaneous dosing is currently being
evaluated in the Clarity AD (Study 301) open-label extension (OLE).
A maintenance dosing regimen has been evaluated as part of Study
201 as well as the Clarity AD (Study 301) OLE. Separate
supplemental Biologics License Applications for subcutaneous dosing
and a maintenance dosing regimen will be submitted to the FDA at
the end of Eisai's fiscal year.
Since July 2020, the Phase 3 clinical study
(AHEAD 3-45) for individuals with preclinical AD, meaning they are
clinically normal and have intermediate or elevated levels of
amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a
public-private partnership between the Alzheimer's Clinical Trial
Consortium that provides the infrastructure for academic clinical
trials in AD and related dementias in the U.S, funded by the
National Institute on Aging, part of the National Institutes of
Health, Eisai and Biogen.
Since January 2022, the Tau NexGen clinical
study for Dominantly Inherited AD (DIAD), that is conducted by
Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led
by Washington University School of Medicine in St. Louis, is
ongoing.
2. About the
Collaboration between Eisai and Biogen for ADEisai and
Biogen have been collaborating on the joint development and
commercialization of AD treatments since 2014. Eisai serves as the
lead of LEQEMBI development and regulatory submissions globally
with both companies co-commercializing and co-promoting the product
and Eisai having final decision-making authority.
3. About the
Collaboration between Eisai and BioArctic for ADSince
2005, Eisai and BioArctic have had a long-term collaboration
regarding the development and commercialization of AD treatments.
Eisai obtained the global rights to study, develop, manufacture and
market LEQEMBI for the treatment of AD pursuant to an agreement
with BioArctic in December 2007. The development and
commercialization agreement on the antibody LEQEMBI back-up was
signed in May 2015.
4. About Eisai Co.,
Ltd.Eisai's Corporate Concept is "to give first thought to
patients and people in the daily living domain, and to increase the
benefits that health care provides." Under this Concept (also known
as human health care (hhc) Concept), we aim to effectively achieve
social good in the form of relieving anxiety over health and
reducing health disparities. With a global network of R&D
facilities, manufacturing sites and marketing subsidiaries, we
strive to create and deliver innovative products to target diseases
with high unmet medical needs, with a particular focus in our
strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to
the elimination of neglected tropical diseases (NTDs), which is a
target (3.3) of the United Nations Sustainable Development Goals
(SDGs), by working on various activities together with global
partners.
For more information about Eisai, please visit
www.eisai.com (for global headquarters: Eisai Co., Ltd.), and
connect with us on Twitter @Eisai_SDGs.
5. About
BiogenFounded in 1978, Biogen is a leading global
biotechnology company that has pioneered multiple breakthrough
innovations including a broad portfolio of medicines to treat
multiple sclerosis, the first approved treatment for spinal
muscular atrophy, and two co-developed treatments to address a
defining pathology of Alzheimer’s disease. Biogen is advancing a
pipeline of potential novel therapies across neurology,
neuropsychiatry, specialized immunology and rare diseases and
remains acutely focused on its purpose of serving humanity through
science while advancing a healthier, more sustainable and equitable
world.
The company routinely posts information that may
be important to investors on its website at www.biogen.com.
Follow Biogen on social media – Twitter, LinkedIn, Facebook,
YouTube.
Biogen Safe HarborThis 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 lecanemab; the potential benefits, safety and
efficacy of lecanemab; potential regulatory discussions,
submissions and approvals and the timing thereof; 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
lecanemab; and risks and uncertainties associated with drug
development and commercialization. These statements may be
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"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 studies may not be indicative of
full results or results from later stage or larger scale clinical
studies 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 studies, including the Clarity
AD clinical trial and AHEAD 3-45 study; the occurrence of adverse
safety events; risks of unexpected costs or delays; the risk of
other unexpected 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 lecanemab; actual timing and content of
submissions to and decisions made by the regulatory authorities
regarding lecanemab; uncertainty of success in the development and
potential commercialization of lecanemab; failure to protect and
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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.
References
- The Centers for Medicare and Medicaid Fact Sheet: CMS announces
new details of plan to cover new Alzheimer’s drugs. CMS announces
new details of plan to cover new Alzheimer’s drugs | CMS. Accessed
June 26, 2023.
-
https://www.alzforum.org/news/conference-coverage/lecanemab-sweeps-toxic-av-protofibrils-catches-eyes-trialists
- Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M,
Nikolajeff F, Lannfelt L, Pettersson FE. Large aggregates are the
major soluble Aβ species in AD brain fractionated with density
gradient ultracentrifugation. PLoS One. 2012;7(2):e32014. doi.
https://doi.org/10.1371/journal.pone.0032014. Epub 2012 Feb 15.
PMID: 22355408; PMCID: PMC3280222.
- Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab,
Aducanumab, and Gantenerumab — Binding Profiles to Different Forms
of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical
Trials for Alzheimer’s Disease. Neurotherapeutics. 2023;20:195-206.
https://doi.org/10.1007/s13311-022-01308-6
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