Recognized in the Medical Care
Category
NUTLEY,
N.J., and CAMBRIDGE,
Mass., Oct. 24, 2023 /PRNewswire/ -- Eisai
Inc. and Biogen Inc. are honored to announce today that TIME has
selected LEQEMBI® (lecanemab-irmb) as one of the Best Inventions of
2023 in the Medical Care category.
LEQEMBI is the first and only approved treatment for patients
with mild cognitive impairment or mild dementia stage of
Alzheimer's disease (AD). AD is a type of dementia that affects
memory and thinking skills as well as behavior impacting a person's
ability to perform daily activities. It is a chronic
neurodegenerative disorder that is both progressive and
irreversible, affecting millions in the U.S. 1,2
TIME's annual list of the Best Inventions features "200
extraordinary innovations changing lives." To compile the list,
TIME solicited nominations from its editors and correspondents
around the world, and through an open online application process,
paying special attention to growing fields such as AI, green
energy, and sustainability. TIME then evaluated each contender on a
number of key factors, including originality, efficacy, ambition,
and impact.
INDICATION
LEQEMBI 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.
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
1. Alzheimer's Association. 2022 Alzheimer's Disease Facts
and Figures. Alzheimers Dement 2022;18. Retrieved July 19, 2022, from
https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf
2. Terracciano A. Sutin AR. Personality and Alzheimer's
disease: An integrative review. Personal Disord. 2019 Jan
10(1):4-12;. Doi:10.1037/per0000268. PMID:30604979; PMCID:
PMC6345278.
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 Reactions
Hypersensitivity 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.
Notes to Editors
1. About LEQEMBI® (lecanemab-irmb)
Lecanemab is the result of a strategic research alliance between
Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma
1 (IgG1) monoclonal antibody directed against aggregated soluble
(protofibril) and insoluble forms of amyloid-beta (Aβ). In the
U.S., LEQEMBI was granted traditional approval by the U.S. Food and
Drug Administration (FDA) on July 6,
2023. LEQEMBI is an amyloid beta-directed antibody indicated
for Alzheimer's disease (AD) in the U.S. Treatment with LEQEMBI
should be initiated in patients with mild cognitive impairment
(MCI) 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. In Japan, Eisai received approval from the
Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023 to manufacture and market
lecanemab as a treatment for slowing progression of MCI and mild
dementia due to AD.
Please see full Prescribing Information, including Boxed
WARNING in the United States.
Eisai has also submitted applications for approval of lecanemab
in EU, China, Canada, Great
Britain, Australia,
Switzerland, South Korea and Israel. In China and Israel, 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.
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 and includes lecanemab as the backbone anti-amyloid
therapy.
2. About the Collaboration between Eisai and
Biogen for AD
Eisai 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 Eisai and Biogen co-commercializing and co-promoting the
product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and
BioArctic for AD
Since 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 Inc.
At Eisai Inc.,
human health care (hhc) is our mission and is the
shared purpose that connects us to those we serve creating a
network of powerful relationships that enables us to identify,
understand and work to address the needs of people throughout their
lives. We boldly push past the boundaries of science and aim to
deliver life-changing therapies and health-related solutions that
matter to people and society. We bring together science, technology
and real-world expertise to pursue a world free from cancer,
Alzheimer's disease and other neurodegenerative diseases.
Everything we do is guided by the simple principle that patients
and their families come first, and we have a responsibility to
listen to and learn from them.
Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. The company's
presence in the U.S. includes three discovery centers as well as
commercial, clinical development and global demand organizations.
To learn more about Eisai, please visit us at www.eisai.com/US and
follow us on X and LinkedIn. For more updates on our work in
neurology, please follow us on LinkedIn and X.
5. About Biogen
Founded 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.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media - X,
LinkedIn, Facebook, YouTube.
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 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 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
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
enforce Biogen's data, intellectual property and other proprietary
rights and uncertainties relating to intellectual property claims
and challenges; 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.
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SOURCE Eisai Inc.; Biogen Inc.