Biologics License Application for Lecanemab Designated for Priority
Review by China National Medical Products Administration
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 Biologics License Application (BLA) for lecanemab
(brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid
beta (Aβ) protofibril antibody, has been designated for Priority
Review by the National Medical Products Administration (NMPA) in
China. The Priority Review and Approval Procedure was implemented
by the NMPA with the aim of accelerating research, development and
launch of new medicines that have significant clinical value. Under
this Procedure, the assessment period is expected to be shortened.
In China, Eisai initiated submission of data for
the BLA to the NMPA in December 2022. Eisai initially submitted a
package that includes data from the Phase II clinical trial (Study
201) and the top-line data of the large global Phase III Clarity AD
study in mild cognitive impairment (MCI) due to Alzheimer’s disease
(AD) and mild AD (collectively known as early AD) with confirmed Aβ
accumulation in the brain. Eisai will submit additional data
including full data of the Clarity AD study, as directed by the
NMPA.
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 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, which was accepted on January 26, 2023.
In Japan, Eisai submitted a marketing authorization application to
the Pharmaceuticals and Medical Devices Agency (PMDA) on January
16, 2023, and Priority Review was designated by the Ministry of
Health, Labour and Welfare (MHLW) on January 26, 2023.
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.
Contacts |
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MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL:
+81-(0)3-3817-5120INVESTOR CONTACT:Eisai Co., Ltd.Investor
Relations DepartmentTEL: +81-(0)3-3817-5122 |
|
MEDIA CONTACT:Biogen Inc.Natacha
Gassenbach+ 1-857-777-6573public.affairs@biogen.comINVESTOR
CONTACT:Biogen Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com |
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[Notes to editors]
1. About Priority
Review and Approval Procedure in China The Priority Review
and Approval Procedure was implemented by the National Medical
Products Administration (NMPA) with the aim of accelerating
research, development and launch of new medicines that have
significant clinical value. Under this Procedure, the assessment
period is expected to be shortened. There are six categories of
priority review designations as follows and lecanemab was
designated as Category 1: 1) Innovative new drugs and new dosage
forms for the prevention and treatment of serious infectious
diseases and rare diseases for which there is an urgent clinical
need. 2) Drugs with additional indications and new dosage forms
that are compatible with the physiological characteristics of
children. 3) Vaccines and innovative vaccines that are urgently
needed to prevent or control disease. 4) Drugs designated as
breakthrough therapies. 5) Medicinal products that are reviewed
under the conditional approval procedure. 6) Other drugs designated
by NMPA for priority review.
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). 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.
Please see full
Prescribing Information.
Eisai has completed lecanemab subcutaneous
bioavailability study, and subcutaneous dosing is currently being
evaluated in the Clarity AD (Study 301) 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, 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.
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
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.
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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
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that could cause actual results to differ materially from those
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