STOCKHOLM, May 22, 2023 /PRNewswire/ -- BioArctic AB's
(publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced
today that they have submitted a Marketing Authorisation
Application (MAA) for lecanemab, an investigational anti-amyloid
beta (Aβ) protofibril[1] antibody,
for the treatment of early Alzheimer's
disease[2] (AD) with confirmed
amyloid pathology in the brain, to the UK Medicines and Healthcare
products Regulatory Agency (MHRA) in Great Britain. Lecanemab has been designated
by the MHRA for the Innovative Licensing and Access Pathway
(ILAP).
The MAA is based on the results of the confirmatory 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, and is subject to a
validation to determine whether it will be accepted by the MHRA.
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.
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 the right to commercialize lecanemab in
the Nordic region and currently Eisai and BioArctic are preparing
for a joint commercialization in the region.
The information was released for public disclosure, through
the agency of the contact person below, on May 22, 2023, at 01.30
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 the Innovative Licensing and Access Pathway (ILAP) in
the UK
The ILAP is a program offered by the MHRA (UK) for development
programs with the goal of reducing the time to market for
innovative medicines that treat life-threatening or seriously
debilitating conditions and/or conditions for which there is a
significant unmet patient need. The ILAP aims to achieve this goal
by enabling enhanced coordination between sponsors, the MHRA and
reimbursement bodies such as National Institute for Health and Care
Excellence (NICE), leading up to Marketing Authorisation
Application (MAA) submissions to support accelerated access.
About lecanemab
Lecanemab 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
(protofibril) and insoluble forms of amyloid-beta (Aβ).
In the US, lecanemab was granted accelerated approval for
Alzheimer's disease by the US 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. This
application was accepted, and has been granted Priority Review,
with a Prescription Drug User Fee Act (PDUFA) action date of
July 6, 2023. In Europe, Eisai submitted a marketing
authorisation application (MAA) to the European Medicines Agency
(EMA) on January 9, 2023, which was
accepted on January 26, 2023. In
Japan, Eisai submitted an
application for manufacturing and marketing approval 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. In China, Eisai initiated submission of data for
a BLA to the National Medical Products Administration (NMPA) of
China in December 2022, which was designated for Priority
Review on February 27, 2023. In
Canada, Eisai submitted a New Drug
Submission (NDS) to Health Canada on March
31, 2023, and was accepted on May
15 of the same year.
Lecanemab is indicated for the treatment of AD in the U.S.
Treatment with lecanemab 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 the accelerated approval based on
reduction in Aβ plaques observed in patients treated with
lecanemab. Continued approval may be contingent upon verification
of lecanemab's clinical benefit in a confirmatory trial.
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 the right to commercialize lecanemab in the Nordic
region and currently Eisai and BioArctic are preparing for a joint
commercialization in the region. BioArctic has no development costs
for lecanemab in Alzheimer's disease and is entitled to payments in
connection with regulatory 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 75-5000 Kd
[2] Mild cognitive impairment due to Alzheimer's
disease (AD) and mild AD dementia
The following files are available for download:
https://mb.cision.com/Main/9978/3772301/2071571.pdf
|
Marketing Authorisation
Application for lecanemab submitted in Great Britain
|
View original
content:https://www.prnewswire.co.uk/news-releases/marketing-authorisation-application-for-lecanemab-submitted-in-great-britain-bioarctic-301830416.html