Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
26 Luglio 2024 - 1:20PM
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 Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
negative opinion on the Marketing Authorization Approval (MAA) for
the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal
antibody lecanemab as treatment for early AD (mild cognitive
impairment due to Alzheimer’s disease (AD) and mild AD).1
“We are extremely disappointed by the CHMP’s
negative opinion and understand that this may also be disappointing
for the wider Alzheimer’s disease (AD) community. AD is an
irreversible, neurodegenerative disease that poses significant
challenges to those living with AD, their care partners and
society,” said Lynn Kramer, M.D., Chief Clinical Officer at Eisai.
“There is a significant unmet need for new innovative treatment
options that target an underlying cause of disease progression. We
remain focused on making a meaningful difference to those living
with early AD and those closest to them.”
Eisai will seek re-examination of the CHMP
opinion and work with the relevant authorities to ensure this
treatment is available for eligible people living with early AD in
the European Union (EU) as soon as possible.
Lecanemab is already approved in the United
States, Japan, China, South Korea, Hong Kong and Israel, and is
being marketed in the U.S., Japan and China.
AD currently affects 6.9 million people in
Europe,2 and this figure is expected to nearly double by 2050 as
aging populations increase.3
Eisai serves as the lead for lecanemab’s
development and regulatory submissions globally with both Eisai and
Biogen co-commercializing and co-promoting the product and Eisai
having final decision-making authority.
MEDIA CONTACTS |
|
Eisai Co., Ltd.Public Relations DepartmentTEL: +81
(0)3-3817-5120Eisai Europe, Ltd. EMEA
Communications Department+44 (0) 786 601
1272Emea-comms@eisai.netEisai Inc. (U.S.)Libby
Holman+1-201-753-1945Libby_Holman@eisai.com |
Biogen Inc.Jack Cox+
1-781-464-3260public.affairs@biogen.com |
INVESTOR
CONTACTS |
|
Eisai Co., Ltd.Investor Relations DepartmentTEL:
+81 (0) 3-3817-5122 |
Biogen Inc.Chuck Triano+
1-781-464-2442IR@biogen.com |
Notes to Editors
- About lecanemab (generic
name, brand name:
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 (Aβ).Lecanemab is
approved in the U.S., Japan, China, South Korea, Hong Kong and
Israel for the treatment of MCI due to AD and mild AD dementia.
Lecanemab’s approvals in these countries were 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.4,5 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.4 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).4 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.4 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).4 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.4Eisai has submitted applications for approval of lecanemab in
12 countries and regions, including the European Union (EU). A
supplemental Biologics License Application (sBLA) for intravenous
maintenance dosing was submitted to the U.S. Food and Drug
Administration (FDA) in March 2024, which was accepted in June
2024. The rolling submission of a Biologics License Application
(BLA) for maintenance dosing of a subcutaneous injection
formulation, which is being developed to enhance convenience for
patients, was initiated in the U.S. under Fast Track status in May
2024.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.
- 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.
- 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.
- 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 X, LinkedIn and Facebook. The
website and social media channels are intended for audiences
outside of the UK and Europe. For audiences based in the UK and
Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.
- About
BiogenFounded in 1978, Biogen is a leading biotechnology
company that pioneers innovative science to deliver new medicines
to transform patient’s lives and to create value for shareholders
and our communities. We apply deep understanding of human biology
and leverage different modalities to advance first-in-class
treatments or therapies that deliver superior outcomes. Our
approach is to take bold risks, balanced with return on investment
to deliver long-term growth.The company routinely posts information
that may be important to investors on its website
at www.biogen.com. Follow Biogen on social media – Facebook,
LinkedIn, X, YouTube. The website and social media channels are
intended for audiences outside of the UK and Europe.Biogen
Safe HarborThis news release contains forward-looking
statements, 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.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; 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
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The foregoing sets forth many, but not all, of the factors that
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References
1 Meeting highlights from the Committee for Medicinal Products
for Human Use (CHMP) 22-25 July 2024
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024.2
Gustavsson, A., et al. Global estimates on the number of persons
across the Alzheimer's disease continuum. Alzheimer’s &
Dementia. 2023;19:658-670.
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12694.
3 Alzheimer Europe. Prevalence of dementia in Europe. Available at:
https://www.alzheimer-europe.org/dementia/prevalence-dementia-europe.4
van Dyck, H., et al. Lecanemab in Early Alzheimer’s Disease. New
England Journal of Medicine. 2023;388:9-21.
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.5 Eisai Global.
2023. Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory
Clarity AD Study for early Alzheimer’s Disease at Clinical Trials
on Alzheimer’s Disease (CTAD) Conference. Available at:
https://www.eisai.com/news/2022/news202285.html. Last accessed:
July 2024.
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