EISAI TO PRESENT LECANEMAB REAL-WORLD EXPERIENCE DATA AND FINDINGS FROM NEUROLOGY PORTFOLIO AT THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING
NUTLEY, N.J., March 25, 2025 /PRNewswire/ -- Eisai Inc. announced today that the company will present the latest findings from its robust neurology portfolio, including data on real-world experience and continued maintenance dosing with our dual-acting, anti-amyloid beta (A ) protofibril* antibody for the treatment of Alzheimer's disease (AD), lecanemab (generic name, U.S. brand name: LEQEMBI(®)) at the American Academy of Neurology (AAN) Annual Meeting, being held in San Diego, California, and virtually from April 5-9. Eisai will present two (2) oral presentations and seven (7) posters on lecanemab and the insomnia dual orexin receptor antagonist DAYVIGO(® )(lemborexant) CIV.
Lecanemab Real World Experience Presentations
On Wednesday, April 9, as part of Poster Session P12, "Aging, Dementia, and Behavioral Neurology: Alzheimer's Treatment" (11:45 AM - 12:45 PM PT), two posters will be presented on real-world experience with lecanemab, including results on efficacy and safety in the clinical setting and patient satisfaction with their treatment experience:
1. Real-World Experience with Long-term Lecanemab Treatment: A Retrospective
Chart Review in Early Alzheimer's Disease (Poster #012)
2. Lecanemab in Clinical Practice: Real-World Treatment Outcomes from a
Retrospective Neurological Clinic Case Series Review in Early Alzheimer's
Disease (Poster #008)
Oral Presentations
Oral presentations include results on lecanemab maintenance dosing, which supports the need for continued treatment of this chronic, progressive disease. Additionally, a cost-effective analysis of lecanemab in Canada will be presented.
"The data presented at AAN highlights not only the breadth and depth of real-world experience with lecanemab compared to clinical trials, but also the importance of ongoing treatment of this chronic progressive disease. Lecanemab clears highly toxic protofibrils that can continue to cause neuronal injury even after the amyloid-beta (A ) plaque has been cleared from the brain," said Lynn D. Kramer, M.D., FAAN, Chief Clinical Officer, Deep Human Biology Learning (DHBL), Eisai. "We are eager to engage in scientific exchange that will continue to advance neurology research and deepen our understanding of lecanemab use in clinical practice, and we remain committed to improving the lives of people who are living with early Alzheimer's disease."
-- Oral Presentations
Session 23: Innovations in Dementia Treatment
Asset/Project,
Presentation Number, Title
Presentation Date
and Time
Lecanemab
Oral Presentation #001 / Abstract ID: 4924
April 8 (Tues.) Cost-Effectiveness of Lecanemab for the Treatment of Early
Alzheimer's
Disease: A Canadian Societal Perspective
1:00 - 1:08 PM PT
Lecanemab
Oral Presentation #007 / Abstract ID: 3687
April 8 (Tues.) Lecanemab Maintenance Dosing in Early Alzheimer's Disease:
Support for
Continued Dosing from Clinical, Pharmacology and Modeling
Data
2:12 - 2:20 PM PT
-- Poster Presentations
Session P1: Aging, Dementia, and Behavioral Neurology: Alzheimer's Disease Diagnostics and Biomarkers
Asset/Project,
Presentation Number, Title
Presentation Date
and Time
Lecanemab
Poster #003 / Abstract ID: 4158
April 5 (Sat.) The Lecanemab Clarity AD Open-Label Extension in Early
Alzheimer's
Disease
11:45 AM - 12:45 PM
PT
Session P12: Aging, Dementia, and Behavior Neurology: Alzheimer's Treatment
Poster Presentation
Presentation Number, Title
Session, Time
Lecanemab
Poster #012 / Abstract ID: 3274
April 9 (Weds.) Real-World Experience with Long-term Lecanemab Treatment:
A
Retrospective Chart Review in Early Alzheimer's Disease
11:45 AM - 12:45 PM PT
Lecanemab
Poster #008 / Abstract ID: 4827
April 9 (Weds.) Lecanemab in Clinical Practice: Real-World Treatment
Outcomes from a
Retrospective Neurological Clinic Case Series Review in
Early Alzheimer's
11:45 AM - 12:45 PM PT Disease
Lecanemab
Poster #006 / Abstract ID: 4653
April 9 (Weds.) Barriers and Solutions for Initiating Monoclonal Antibody
Therapy in
Alzheimer's Disease
11:45 AM - 12:45 PM PT
Lecanemab
Poster #019 / Abstract ID: 2639
April 9 (Weds.) Lecanemab Treatment in Real World Settings in the United
States
11:45 AM - 12:45 PM PT
Lecanemab
Poster #001 / Abstract ID: 1555
April 9 (Weds.) Cerebellar ARIA in a Patient With an APP Duplication Treated
With
Lecanemab
11:45 AM - 12:45 PM PT
Session P9: Sleep 3
Poster Presentation
Presentation Number, Title
Session, Time
Lemborexant
Poster #004 / Abstract ID: 1947
April 8 (Tues.) Impact of Lemborexant on Daytime Sleepiness/Alertness in
Participants With
Comorbid Insomnia and Mild Obstructive Sleep Apnea
11:45 AM - 12:45 PM PT
-- Industry Therapeutic Updates Sponsored by Eisai Inc.
Asset/Project,
Presentation Number, Title
Presentation Date
and Time
Lecanemab Talking with Patients and Care Partners About Early AD
Treatment:
Communicating the Rationale for Early, Ongoing Therapy
April 6 (Sun.)
11:45 AM - 12:45 PM PT
April 7 (Mon.) Driving Change for Anti-amyloid Therapy Implementation:
Overcoming
Challenges Across Practice Settings
11:45 AM - 12:45 PM PT
This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
* Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of A , having a primary role in the cognitive decline associated with this progressive, debilitating condition.(1) Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble A plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.(2)
[Notes to editors]
1. About lecanemab (LEQEMBI(®))Lecanemab is the result of a strategic
research alliance between Eisai and BioArctic. It is a humanized
immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against
aggregated soluble (protofibril) and insoluble forms of amyloid-beta (A
). Lecanemab is approved in the U.S.,(3) Japan,(4) China,(5) South
Korea,(6) Hong Kong,(7) Israel,(8) the United Arab Emirates,(9) the
United Kingdom,(10) Mexico,(11) Macau and Oman. Eisai has submitted
applications for approval of lecanemab in 17 countries and regions. In
the EU, in February 2025, the Committee for Medicinal Products for Human
Use reaffirmed its positive opinion for lecanemab in early AD, adopted in
November 2024, and the European Commission is proceeding with the
decision-making process for lecanemab's marketing authorization.LEQEMBI's
approvals in these countries was based on Phase 3 data from Eisai's,
global Clarity AD clinical trial, in which it met its primary endpoint
and all key secondary endpoints with statistically significant results.
The primary endpoint was the global cognitive and functional scale,
Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD
clinical trial, treatment with lecanemab reduced clinical decline on
CDR-SB by 27% at 18 months compared to placebo.(12,13) The mean CDR-SB
score at baseline was approximately 3.2 in both groups. The adjusted
least-squares mean change from baseline at 18 months was 1.21 with
lecanemab and 1.66 with placebo (difference, -0.45; 95% confidence
interval [CI], -0.67 to -0.23; P<0.001). In addition, the secondary
endpoint from the AD Cooperative Study-Activities of Daily Living Scale
for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information
provided by people caring for patients with AD, noted a statistically
significant benefit of 37% compared to placebo. The adjusted mean change
from baseline at 18 months in the ADCS-MCI-ADL score was -3.5 in the
lecanemab group and -5.5 in the placebo group (difference, 2.0; 95% CI,
1.2 to 2.8; P<0.001). The ADCS MCI-ADL assesses the ability of patients
to function independently, including being able to dress, feed themselves
and participate in community activities. The most common adverse events
(>10%) in the lecanemab group were infusion reactions, ARIA-H (combined
cerebral microhemorrhages, cerebral macrohemorrhages, and superficial
siderosis), ARIA-E (edema/effusion), headache, and fall.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 ADEisai and Biogen
have been collaborating on the joint development and commercialization of
AD treatments since 2014. Eisai serves as the lead of lecanemab
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 lecanemab for the
treatment of AD pursuant to an agreement with BioArctic in December 2007.
The development and commercialization agreement on the antibody lecanemab
back-up was signed in May 2015.
4. About Lemborexant (DAYVIGO(®))Lemborexant, an orexin receptor
antagonist, is Eisai's in-house discovered and developed small molecule
that inhibits orexin neurotransmission by binding competitively to the
two subtypes of orexin receptors (orexin receptor 1 and 2). In
individuals with normal daily sleep-wake rhythms, orexin signaling is
believed to promote periods of wakefulness. In individuals with
sleep-wake disorders, it is possible that orexin signaling which
regulates wakefulness is not functioning normally, suggesting that
inhibiting inappropriate orexin signaling may enable initiation and
maintenance of sleep. It has been approved for the treatment of insomnia
in over 15 countries including Japan, the United States, Canada,
Australia and countries in Asia.
References
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displayed by fibril ends and neurotoxic oligomers. Nat Commun.
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2. Ono K, Tsuji M. Protofibrils of Amyloid- are Important Targets of a
Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci.
2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID:
PMC7037706.
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Medical Product Directory. Leqembi. Last accessed: October 2024.
10. BioSpace. 2024. Leqembi authorized for early Alzheimer's disease in
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12. van Dyck, C., et al. Lecanemab in Early Alzheimer's Disease. New England
Journal of Medicine. 2023;388:9-21.
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13. Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD
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https://www.eisai.com/news/2022/news202285.html.
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