STOCKHOLM, Jan. 30,
2023 /PRNewswire/ -- BioArctic AB's (publ)
(NASDAQ Stockholm: BIOA B) partner Eisai announced today that
the application for manufacturing and marketing approval for
lecanemab (generic name, U.S. brand name: LEQEMBI™) in Japan has been designated for Priority Review
by the Japanese Ministry of Health, Labour and Welfare (MHLW).
Lecanemab is an anti-amyloid-β (Aβ)
protofibril[1] antibody for treatment of
Alzheimer's disease (AD). 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 3 Clarity AD study and the Phase
2b clinical study, 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,
which was 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. BioArctic has right to commercialize lecanemab in the
Nordic under certain conditions and is currently preparing for
commercialization in the Nordics together with Eisai. BioArctic has
no development costs for lecanemab in Alzheimer's disease and is
entitled to payments in connection with regulatory filings,
approvals, and sales milestones as well as royalties on global
sales.
---
This information is information that BioArctic AB (publ) is
obliged to disclose pursuant to the EU Market Abuse Regulation. The
information was released for public disclosure, through the agency
of the contact person below, on January 30,
2023, at 00.30 a.m.
CET.
For further information, please contact:
Oskar Bosson, VP Communications and
IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
About Priority Review in Japan
Priority 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; and
ii. 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.
About lecanemab
Lecanemab (Brand Name in the U.S.: LEQEMBI™) is the result of a
strategic research alliance between BioArctic and Eisai. Lecanemab
is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody
directed against aggregated soluble and insoluble forms of
amyloid-beta (Aβ). Lecanemab selectively binds and eliminates Aβ
protofibrils that are thought to contribute to the neurotoxicity in
Alzheimer's disease. 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 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 LEQEMBI US Prescribing Information.
Eisai has completed a lecanemab subcutaneous bioavailability
study and subcutaneous dosing is currently being evaluated in the
Clarity AD open label extension study.
Since July 2020 Eisai's 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 and Eisai.
Since January 2022, the Tau NexGen
clinical study for Dominantly Inherited AD (DIAD) is ongoing, where
lecanemab is given as a background anti-amyloid treatment when
exploring combination therapies with anti-tau treatments. The study
is conducted by Dominantly Inherited Alzheimer Network Trials Unit
(DIAN-TU), led by Washington University
School of Medicine in St.
Louis.
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai
regarding the development and commercialization of drugs for the
treatment of Alzheimer's disease. The most important agreements are
the Development and Commercialization Agreement for the lecanemab
antibody, which was signed in December
2007, and the Development and Commercialization agreement
for the antibody BAN2401 back-up for Alzheimer's disease, which was
signed in May 2015. In March 2014, Eisai and Biogen entered into a joint
development and commercialization agreement for lecanemab. Eisai is
responsible for the clinical development, application for market
approval and commercialization of the products for Alzheimer's
disease. BioArctic has right to commercialize lecanemab in the
Nordic under certain conditions and is currently preparing for
commercialization in the Nordics together with Eisai. BioArctic has
no development costs for lecanemab in Alzheimer's disease and is
entitled to payments in connection with regulatory filings,
approvals, and sales milestones as well as royalties on global
sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company
focusing on disease-modifying treatments for neurodegenerative
diseases, such as Alzheimer's disease, Parkinson's disease and ALS.
BioArctic focuses on innovative treatments in areas with high unmet
medical needs. The company was founded in 2003 based on innovative
research from Uppsala University,
Sweden. Collaborations with
universities are of great importance to the company together with
its strategically important global partner Eisai in Alzheimer
disease. The project portfolio is a combination of fully funded
projects run in partnership with global pharmaceutical companies
and innovative in-house projects with significant market and
out-licensing potential. BioArctic's Class B share is listed on
Nasdaq Stockholm Large Cap (ticker: BIOA B). For more information
about BioArctic, please visit www.bioarctic.com.
[1] Protofibrils are large Aβ aggregated soluble
species of 75-500 Kd
The following files are available for download:
https://mb.cision.com/Main/9978/3705136/1811899.pdf
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Lecanemab receives
priority review status in Japan
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SOURCE BioArctic