FDA Accepts BLA and Grants Priority Review for Lecanemab for Treatment of Early-onset Alzheimer’s Disease Under Accelerated Pathway

STOCKHOLM, July 6, 2022 /PRNewswire/ — BioArctic AB’s (ad) (Nasdaq Stockholm: BIOA B) Partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code : BAN2401), an investigational protofibril anti-amyloid beta (Aβ) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively referred to as early AD), with confirmed presence of amyloid pathology in the brain. Eisai’s request, which was completed early May 2022was granted priority review with an action date under the Prescription Drug User Fees Act (PDUFA) on January 6, 2023. Acceptance of the BLA by the FDA entitles BioArctic to a milestone payment of EUR 15 million from Eisai.

The confirmatory Phase 3 Clarity AD clinical trial for lecanemab in early AD is ongoing and enrollment of 1,795 patients was completed in March 2021. The reading of data on the primary endpoints of the trial will take place in the fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can be used as a confirmatory study to verify clinical benefit of lecanemab. Eisai used the FDA’s accelerated approval pathway in an effort to streamline the submission process for potential traditional lecanemab approval to expedite patient access to lecanemab. Based on the results of the Clarity AD clinical trial, Eisai will submit lecanemab traditional approval to the FDA before the end of Q1 2023.

“For nearly 20 years now, BioArctic’s vision has been to develop innovative medicines for people with neurological disorders such as Alzheimer’s disease, a disease that affects millions of people worldwide. The FDA’s acceptance of the BLA and granting of priority review for lecanemab brings another step forward in our quest to address the enormous medical need of this patient population,” said Gunilla OsswaldCEO of BioArctic.

Lecanemab obtained Breakthrough Therapy and Fast Track designations from the FDA in June and December 2021, respectively. In March 2022Eisai has initiated the submission of application data to from Japan Medicines and Medical Devices Agency (PMDA) as part of the prior assessment consultation mechanism, with the aim of obtaining early approval for lecanemab. Eisai aims to file for manufacturing and marketing approval based on the results of Clarity AD in the United States, Japan and in the EU before the end of the first quarter of 2023.

This release discusses experimental uses of an agent under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any experimental use of such a product will successfully complete clinical development or obtain approval from health authorities.

For more information, please contact:

Gunilla OsswaldCEO

Email: [email protected]

Telephone: +46 8 695 69 30

Oskar BossonVP Communications and IR

E-mail: [email protected]

Telephone: +46 70 410 71 80

This information is information that BioArctic AB (publ) is required to disclose under the EU Market Abuse Regulation. The information has been released for public disclosure, through the above contact persons, the July 6, 2022at 01:30 CET.

About Lecanemab (BAN2401)

Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s disease (AD) that is the result of a strategic research alliance between BioArctic and Eisai. Lecanemab selectively binds, neutralizes and removes soluble toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may affect disease pathology and slow disease progression. Eisai has been granted worldwide rights to study, develop, manufacture and commercialize lecanemab for the treatment of AD pursuant to an agreement entered into with BioArctic in December 2007. In March 2014, Eisai and Biogen have entered into a joint development and commercialization agreement for lecanemab. Currently, lecanemab is undergoing a pivotal phase 3 clinical study in symptomatic early AD (Clarity AD), following the results of the phase study 2b clinical study (Study 201). Additionally, the Phase 3 clinical study, AHEAD 3-45, for people with preclinical (asymptomatic) AD, meaning they are clinically normal and have intermediate or high levels of brain amyloid, is in progress. Classes. AHEAD 3-45 is being conducted through a public-private partnership between the Alzheimer’s Clinical Trial Consortium, funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai. In 2021, DIAN-TU selected lecanemab for a clinical trial in dominant hereditary Alzheimer’s disease as a background anti-amyloid therapy when exploring combination therapies with anti-tau treatments in subjects with Dominant hereditary Alzheimer’s disease. In June 2021the FDA granted Breakthrough Therapy Designation to lecanemab and in December 2021, the FDA has granted fast track designation to lecanemab. In addition, Eisai has completed a Phase 1 subcutaneous dosing study of lecanemab and the subcutaneous formulation is currently being evaluated in the Clarity AD open-label extension study.

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most significant agreements are the lecanemab antibody development and commercialization agreement, which was signed in December 2007and the development and commercialization agreement for the BAN2401 back-up antibody for Alzheimer’s disease, which was signed in May 2015. Eisai is responsible for the clinical development, marketing authorization application and commercialization of products for Alzheimer’s disease. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments related to regulatory filings, approvals and sales milestones as well as royalties on worldwide sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharmaceutical company focused 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 for the company with its global strategic partner Eisai in Alzheimer’s disease. The project portfolio is a combination of fully funded projects managed in partnership with global pharmaceutical companies and innovative internal projects with significant market and licensing potential. BioArctic’s Class B stock is listed on the Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information on BioArctic, please visit www.bioarctic.com.

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