Lecanemab Receives Priority Review Status in Japan
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 an application for manufacturing and marketing approval
for lecanemab (generic name, U.S. brand name: LEQEMBI™), an
anti-amyloid-β (Aβ) protofibril* antibody, in Japan has been
designated for Priority Review by the Japanese Ministry of Health,
Labour and Welfare (MHLW). Priority Review in Japan is granted to
new medicines recognized as having high medical utility for serious
diseases, and once designated for Priority Review, the target total
review period is shortened.
In Japan, Eisai submitted the manufacturing and
marketing approval for lecanemab to the Pharmaceuticals and Medical
Devices Agency (PMDA) on January 16, 2023. This application is
based on the results of the Phase III Clarity AD study and the
Phase IIb clinical study (Study 201), which demonstrated that
lecanemab treatment showed a reduction of clinical decline in early
AD.
Lecanemab selectively binds and eliminates
soluble, toxic Aβ aggregates (protofibrils) that are thought to
contribute to the neurotoxicity in AD. As such, lecanemab may have
the potential to have an effect on disease pathology and to slow
down the progression of the disease. The Clarity AD study of
lecanemab met its primary endpoint and all key secondary endpoints
with highly statistically significant results. In November 2022,
the results of the Clarity AD study were presented at the 2022
Clinical Trials on Alzheimer’s Disease (CTAD) conference and
simultaneously published in the New England Journal of Medicine, a
peer-reviewed medical journal.
In the U.S., lecanemab was granted accelerated
approval as a treatment for AD by the U.S. Food and Drug
Administration (FDA) on January 6, 2023. On the same day, Eisai
submitted a Supplemental Biologics License Application (sBLA) to
the FDA for approval under the traditional pathway. In Europe,
Eisai submitted a marketing authorization application (MAA) to the
European Medicines Agency (EMA) on January 9, 2023 and accepted on
January 26, 2023. In China, Eisai initiated submission of data for
a BLA to the National Medical Products Administration (NMPA) in
December 2022.
Eisai serves as the lead of lecanemab
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 75-500 Kd. 1,2
Contacts |
MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL:
+81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+
1-201-753-1945Libby_Holman@eisai.com INVESTOR CONTACT:Eisai
Co., Ltd.Investor Relations DepartmentTEL: +81-(0)03-3817-5122 |
MEDIA CONTACT:Biogen Inc.Natacha Gassenbach +
1-857-777-6573public.affairs@biogen.comINVESTOR CONTACT:Biogen
Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com |
[Notes to editors]
1. About Priority Review in
JapanPriority review is granted to medicines that meet all
of the following requirements. In addition, medicines designated as
orphan drugs and pioneering medicines will be given priority for
review.i. the qualifying disease is deemed to be serious; andii.
the efficacy or safety of the product is recognized to be clearly
superior to that of existing medicines, medical devices, or
regenerative medical products or treatment methods from a medical
point of view.
2. About
Lecanemab Lecanemab (Brand Name in the U.S.: LEQEMBI™) 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). Lecanemab
selectively binds and eliminates Aβ protofibrils that are thought
to contribute to the neurotoxicity in AD. As such, lecanemab may
have the potential to have an effect on disease pathology and to
slow down the progression of the disease. In the U.S., LEQEMBI was
granted accelerated approval by the U.S. Food and Drug
Administration (FDA) on January 6, 2023. LEQEMBI is indicated for
the treatment of Alzheimer’s disease (AD) in the U.S. 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. This indication is
approved under accelerated approval based on reduction in Aβ
plaques observed in patients treated with LEQEMBI. Continued
approval for this indication may be contingent upon verification of
clinical benefit in a confirmatory trial. The Clarity AD study of
lecanemab met its primary endpoint and all key secondary endpoints
with highly statistically significant results.
Please see full
Prescribing Information in the United
States.
Eisai submitted an application for manufacturing
and marketing approval to the Pharmaceuticals and Medical Devices
Agency (PMDA) on January 16, 2023 in Japan. Eisai utilized the
prior assessment consultation system of PMDA, with the aim of
shortening the review period for lecanemab. In the U.S., Eisai
submitted a Supplemental Biologics License Application (sBLA) to
the FDA for approval under the traditional pathway on January 6,
2023. In Europe, Eisai submitted a marketing authorization
application (MAA) to the European Medicines Agency (EMA) on January
9, 2023 and accepted on January 26, 2023. In China, Eisai initiated
submission of data for a BLA to the National Medical Products
Administration (NMPA) of China in December 2022.
Eisai has completed a lecanemab subcutaneous
bioavailability study, and subcutaneous dosing is currently being
evaluated in the Clarity AD OLE.
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, has been 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 the
Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led
by Washington University School of Medicine in St. Louis, has been
ongoing.
3. 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.
4. 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.
5. 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), with 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.
6. 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 a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first approved treatment to address a
defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
We routinely post information that may be
important to investors on our website at www.biogen.com. Follow us
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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
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Results in early-stage clinical studies may not be indicative of
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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
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References
- “Lecanemab Sweeps up Toxic AΒ
Protofibrils, Catches Eyes of Trialists.” ALZFORUM, ALZFORUM, 21
Nov. 2021,
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: 10.1371/journal.pone.0032014. Epub 2012 Feb
15. PMID: 22355408; PMCID: PMC3280222.
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